Penile implant

ABSTRACT

Penile implant and system comprising such an implant. The penile implant comprises a number of features which improves the function of the penile implant, e.g. a certain surface structure and portions with specific functions.

This application is a continuation of U.S. application Ser. No.13/146,730, filed 28 Jul. 2011, which is the US national phase ofInternational Application No. PCT/SE2010/050091, filed 29 Jan. 2010,which designated the US and claims priority to Swedish application Nos.090093-6, filed 29 Jan. 2009; 0900094-4, filed 29 Jan. 2009; 0900095-1,filed 29 Jan. 2009; and 0900096-9, filed 29 Jan. 2009, the entirecontents of each of which are hereby incorporated by reference.

TECHNICAL FIELD

The present invention relates to an implantable device, in particular apenile implant for curing erectile impotence, a system comprising such adevice and methods of implanting such a device and system.

BACKGROUND

As regards implants, and in particular penile implants for curingerectile impotence, known from the background art, there are a number ofareas or aspects where there is room for improvement.

One problem often encountered is the formation of fibrotic tissue oraccumulation of fibrotic cells on the surface of the implant. Theformation of such tissue on the surface of a penile implant maynegatively influence the function of the implant, e.g. if such tissue isformed on a part of the surface that is collapsible and/or expandable.

In the background art expandable/collapsible breast implants are known,see e.g. U.S. Pat. No. 6,875,233 B1. The pleats of the implant describedin this document may be prone to be bridged by fibrotic tissue which mayimpede the function of the implant. Further, the technique shown in thisdocument may be unsuitable for use in a penile implant since theconditions and demands may differ between penile implants and breastimplants.

See also U.S. Pat. No. 4,424,807 which shows a penile implant where thefolded or overlapped portions 50 and the folded ends 44 and 46 may beprone to be bridged or covered by fibrotic tissue which may impede thefunction of the implant.

Another problem often encountered with previously known implants,especially in connection with penile implants, is that there is a riskthat the penile implant breaks when it is subjected to bending. A penileimplant is e.g. often subjected to bending in its relaxed state and inthe bended area there is an evident risk of damage or breaking of thepenile implant. See e.g. U.S. Pat. No. 4,424,807 which shows a penileimplant subjected to bending in its relaxed state.

One further problem often encountered with previously known penileimplants is that the angle of the penis when activated by the penileimplant is unnatural and does not correspond to the angle of an erectednormally functioning penis. A normally functioning penis is bent upwardto some extent, there are of course individual variations, when erectedbut previously known penile implants often result in an erected penisthat is not bent upwards but solely stands straight out from the bodyunder an angle of approximately 90 degrees. See e.g. U.S. Pat. No.4,424,807 which shows a previously known penile implant as described.

Another problem often encountered with previously known implants,especially in connection with penile implants, is that a quite largeamount of hydraulic fluid is needed to fill the penile implant when thepenile implant is activated. This leads to a delay in the activation ofthe penile implant and to a relatively large reservoir for the hydraulicfluid. The larger the reservoir for the hydraulic fluid is, the moredifficult it is to invasively place it, e.g. in the scrotum, andpotentially the more inconvenient it is for the patient to have thereservoir invasively placed in the body. To have a large amount ofhydraulic fluid in the activated penile implant also makes the penileimplant heavy which may be dissuitable. See e.g. U.S. Pat. No. 4,424,807which shows a previously known penile implant as described.

Another problem often encountered with previously known penile implantsis that there is no radial or longitudinal expansion of the penileimplant when filled with hydraulic fluid. In contrast, a natural corpuscavernosum undergoes a radial and longitudinal expansion when filledwith blood. There is previously known penile implants having provisionsfor radial and longitudinal expansion, see e.g. U.S. Pat. No. 4,424,807,but these provisions have less favorable characteristics in certainaspects. In the case of U.S. Pat. No. 4,424,807, as mentioned before,the folded or overlapped portions 50 and the folded ends 44 and 46 maybe prone to be bridged or covered by fibrotic tissue.

A further problem with previously known implants is that they do notprovide any remedy for dysfunctional ejaculation.

Also other solutions than those cited above are known in this field, oneknown solution to achieve erection is to restrict the blood flow leavingthe penis. For example, U.S. Pat. No. 4,828,990 discloses twohydraulically operated inflatable cuffs wrapped around respective cruraor veins. A disadvantage of such a solution is that it involvescomplicated surgery.

Another known solution according to U.S. Pat. No. 4,828,544 comprises anartificial fistula system surgically implanted and providing a primaryfistula between the femoral artery and the femoral vein and a secondaryfistula for leading blood from the primary fistula to the penis. Aninflatable balloon engages the primary fistula between the secondaryfistula and the vein. The balloon is in fluid connection with a manuallycompressible reservoir implanted in the scrotum. Again, implantation ofthis artificial fistula system requires delicate surgery. Anotherdisadvantage, to such a solution, is the fact that the venous bloodvessel system is rather complex and it is difficult to restrict the veinplexa.

Yet another known solution, for example disclosed in U.S. Pat. Nos.3,855,122, 3,954,102, 4,009,711, 4,201,202, 4,235,222, 4,318,396,5,250,020 and 4,424,807, currently practiced is to replace the corpuscavernosa in the penis with a hydraulic inflatable/contractable siliconeprosthesis thus implanted in the penis. In fluid connection with thisprosthesis is a balloon-like reservoir implanted in the scrotum. Bymanual pumping action the prosthesis is filled with fluid from thereservoir to effect erect penile condition or is emptied of fluid, whichreturns to the reservoir, to effect flaccid penile condition.

It is an aim to provide a technique that leads to improvement regardingall or at least some of the areas or aspects discussed above.

SUMMARY

According to one aspect of the invention there is provided a surfacestructure for a penile implant, especially an elongated penile implantor penile prosthesis for curing erectile impotence, and an implantabledevice having such a surface structure, where the surface structure hasdefined distances between the elements of the structure. The distancesare big enough to prevent or limit fibrotic tissue from bridging theelements or connecting the elements in such a way as to impede thefunction of the implant.

Fibrotic tissue can often have an extension or thickness of about 0.5 mmto about 1.5 mm and hence the distances between relevant surfaces of theelements of the surface structure are suitably greater than about 3 mm,hence greater than about 2×1.5 mm. But depending on the circumstancesalso distances greater than about 1.0 mm to about 3 mm may besufficient. In cases where the fibrotic tissue can be expected to havean extension or thickness greater than about 1.5 mm the distancesbetween relevant surfaces of the elements of the surface structure areadapted in a suitable manner.

The surface structure may comprise elevated and lowered areas and it maybe suitable that also a distance between the different planes of theelevated and lowered areas is bigger than a certain threshold tofacilitate the collapsible and/or expandable functionality of theimplant. If said distance is too small, the collapsible and/orexpandable functionality of the penile implant may be limited. Asuitable interval for said distance is around 0.5 to 10 mm, moresuitable around 2-8 mm and most suitable around 3-7 mm The surfacestructure may comprise different geometrical elements or shapes and anycombination of such elements or shapes as long as the above mentionedconditions for the distances can be met. The surface structure may e.g.comprise ridges and grooves of different shapes. The ridges and groovesmay each have a cross-section that is e.g. wedge-shaped, polygonal,square-formed, pyramidal-shaped, truncated pyramidal-shaped. Further maythe ridges and grooves have cross-sections of different shape. Thesurface structure may as well in general comprise a bellows-shapedstructure or a surface structure where geometrical objects of the sameor different kind(s) are placed on a surface. The geometrical objectsmay be practically randomly placed on the surface or according to somescheme.

One type of implants where this type of surface structure is suitable,is penile implants where the penile implant should have the ability tochange shape and/or size substantially. Hence, this is a case where thepresence of fibrotic tissue substantially could hinder or impede thefunction of the implant. But the surface structure may be used by anyimplant where the characteristics of the surface structure would besuitable for the implant.

According to another aspect of the invention there is provided a penileimplant or penile implantable device, in particular an elongated penileimplant or penile prosthesis for curing erectile impotence, having apre-formed section. The pre-formed section may suitably comprise asurface shape having at least one fold, pleat or bellow shaped part orpart having a smooth surface, or combinations thereof. This to mentionsome examples. The pre-formed section is suitably in a position or areawhere the penile implant often is bent. For a penile implant onesuitable position for the pre-formed section is a point or area of thepenile implant which is in the vicinity of and/or including the positionwhere the protruding part of the penis starts. With the protruding partof the penis it is meant the part of the penis that is visible on theoutside of the body, also called pendulous part. Suitably the pre-formedsection is shaped in a way as to give the penile implant a shape thatcorresponds to or resembles the shape that the penile implant has mostof the time. This may be suitable to minimize the stress on the materialof the implant. In the case of a penile implant it can e.g. be assumedthat the penile implant is relaxed most of the time. Hence, it issuitable that the pre-formed section is shaped in a way as to give thepenile implant a shape that corresponds to or resembles the shape of arelaxed penis. The pre-formed section suitably has a certain extensionin the longitudinal direction of the penile implant, here calledlongitudinal extension. The longitudinal extension of the pre-formedsection is suitably in the interval of around 5-150 mm, depending on thecircumstances, e.g. the length of the penile implant. It may be suitablethat the pre-formed section has a longitudinal extension that is around10-40 percent of the total longitudinal extension of the penile implant.The pre-formed section may comprise a substantially saw tooth shapedsurface, or any other suitable surface shape which enables anappropriate function of the pre-formed section, e.g. any of the surfaceshapes or elements described in the section of this applicationregarding the surface structure having elevated and lowered areas. Thesurface shape(s) of the pre-formed section may extend along a part of,parts of or the complete circumference of the pre-formed section. In thecase of a substantially saw tooth shaped surface, or any other surfaceshape comprising ridges and grooves, e.g. a square wave shaped surfaceor a wave shaped surface, it is suitable that the ridges and groovesextend in a substantially circumferential direction of the penileimplant and that the ridges and grooves are placed alternating one afterthe other in a substantially longitudinal direction of the implant. Byproviding an implant, in particular a penile implant, with a pre-formedsection as described, the risk for breaking of, or damage to, the penileimplant is reduced and may even be substantially eliminated.

According to another aspect of the invention there is provided an penileimplant or penile implantable device, in particular an elongated penileimplant or penile prosthesis for curing erectile impotence, comprisingbending portion giving the penile implant a desired angle whenactivated, e.g. filled with hydraulic fluid. For a penile implant saidbending portion gives the activated penile implant an upwardly bentposition. That is, when said penile implant is invasively placed in thecorpus cavernosum, suitably one penile implant in each corpuscavernosum, in the penis of a standing person, frequently a man, andactivated, said implant, and hence also the penis, assumes an upwardlybent position. With upwardly bent is meant that the penis has an acuteangle with a vertical plane, said angle being measured from the upperside of the penis towards a vertical plane when said person is standing.Suitably said vertical plane is substantially parallel with the body ofsaid standing person. Said bending portion may e.g. comprise that thepenile implant has a bellows structure and/or a pliable wall part atleast in the area where the penile implant is bent, or should be able tobe bent. Further, the bending portion, e.g. a bellows structure or apliable wall part, on one side of the penile implant is designed to showa greater length expansion when the penile implant is activated than thebending portion on the other side of the implant. Said bending portionmay e.g. be positioned at a point or in an area of the penile implantwhich is in the vicinity of and/or including the position where theprotruding part of the penis starts. The bending portion that shouldshow a greater length expansion when the penile implant is activated maye.g. have a greater area. This may e.g. be achieved in that the bendingportion has a greater longitudinal extension on one side of the penileimplant than on the other side. Another possibility is that, in case ofa bellows structure, the bellows structure has a greater depth, at leastwhen the penile implant is in- or non-activated, on one side of thepenile implant than on the other side, to enable a greater lengthexpansion of the bellows structure having the greater depth. These twopossibilities may of course also be combined. In the A bellows structureoften has a surface structure which can be said to comprise ridges andgrooves. For measuring the depth of a bellows structure one may measurethe distance between the bottom of a groove and the top of a ridge. Withlength expansion is meant an expansion in the longitudinal direction ofthe implant, with longitudinal extension it is meant an extension in thelongitudinal direction of the implant. Said device suitably comprises arelatively short proximal portion, which is to be anchored in the rootof the penis, or placed in the part of the corpus cavernosum that islocated inside the body, and a flexible relatively long, distal portion.Said distal portion suitably extends along the pendulous part of thepenis, wherein said bending portion is positioned at or on said proximalportion, suitably in the vicinity of the position where said proximalportion and said distal portion meet. Suitably the distal portion islonger than the proximal portion, as is indicated by the expressions“relatively short proximal portion” and “relatively long, distalportion”. The longitudinal extension of the bending portion is suitablyin the interval of around 5-150 mm, depending on the circumstances, e.g.the length of the penile implant. It may be suitable that the bendingportion has a longitudinal extension that is around 10 to 40 percent ofthe total longitudinal extension of the penile implant. The depth of thebellows structure is suitably in the interval of around 0.5 to 5 mm,even more suitable around 1-4 mm and most suitably around 1.5-3 mm,depending on the circumstances, e.g. the desired angle of the penis whenthe penile implant is activated.

The bending portion may comprise a substantially saw tooth shapedsurface, or any other suitable surface shape which enables anappropriate function of the bending portion, e.g. any of the surfaceshapes or elements described in the section of this applicationregarding the surface structure having elevated and lowered areas. Thesurface shape(s) of the bending portion may extend along a part of,parts of, or the complete, circumference of the bending portion. In thecase of a substantially saw tooth shaped surface, or any other surfaceshape comprising ridges and grooves, e.g. a square wave shaped surfaceor a wave shaped surface, it is suitable that the ridges and groovesextend in a substantially circumferential direction of the penileimplant and that the ridges and grooves are placed alternating one afterthe other in a substantially longitudinal direction of the implant.Evidently, to achieve the desired effect the penile implant should beinvasively placed in the corpus cavernosum so that the bellows structuredesigned to show the greater length expansion when the penile implant isactivated, is on the underside of the penile implant. It is alsopossible that the bellows structure covers a part, or parts, of thecircumference of the implant. The bellows structure may e.g.substantially only cover the underside of the implant, or it maysubstantially cover the underside and the upper side but not the sidesof the implant. The reference for the expressions “underside” and “upperside” is the situation that the penile implant is placed in the corpuscavernosum of a standing person, frequently but not necessarilyexclusively, a standing man in the case of a penile implant. Oneadvantage with said bending portion is that the penis will have anatural angle when the penile implant is activated. This is an advantagee.g. since it is more comfortable for the patient when the penis has anatural appearance in its erected state and since sexual intercourse canbe performed in a more natural way.

According to a further aspect of the invention there is provided anpenile implant or penile implantable device, in particular an elongatedpenile implant or penile prosthesis for curing erectile impotence, wherethe penile implant comprises a hollow part comprising a foam or asimilar material, hereafter called foam material. The hollow part maye.g. be implemented in that the penile implant itself is hollow orcomprises a hollow body. The hollow part can be filled with atransportable medium to activate the implant. The transportable mediummay e.g. be a fluid such as a gas or a liquid. Suitably the foammaterial is transparent for or to fluid and occupies at least part ofthe volume defined by the hollow part. Transparent for or to fluid meansthat the foam material comprises or defines open spaces that can befilled with fluid. In this way the amount of transportable medium thatis needed to fill the hollow part is reduced as compared to the casewhere the hollow part has to be completely filled with the transportablemedium. This is an advantage e.g. since the weight of the penile implantwhen activated is reduced and the hollow part can be filled withtransportable medium more quickly. This is suitable for the patienthaving the penile implant implanted. To further reduce the weight of thepenile implant when activated, the foam material may comprise a closedcellular foam material comprising closed spaces containing a, suitablylow density, solid material, gas or fluid, e.g. air or foam material.

Foam materials of the closed cellular type have pores or cells that arenot interconnected and are sealed off to an external surface. Hence, theinside of the closed spaces do not come in contact with thetransportable medium. Suitably the foam material comprises a flexiblefoam material.

According to yet another aspect of the invention there is provided anpenile implant or penile implantable device, in particular an elongatedpenile implant or penile prosthesis for curing erectile impotence, wherethe penile implant is adjustable in size between a collapsed state andan expanded state. Suitably the penile implant comprises at least oneexpandable portion. The penile implant may also be adjustable in sizebetween a collapsed state and one or more expanded states. In theexpanded states the penile implant may be fully or partly expanded.

To achieve that the penile implant has the required stiffness to makethe penis erect and hard also when the penile implant is in a partlyexpanded state, the expandable portion suitably is designed or adaptedto present the necessary stiffness already when the expandable portionis partly expanded. This may be achieved by designing the expandableportion so that it presents an appropriate resistance against furtherexpansion already when the expandable portion is partly expanded. Thehigher resistance an object presents against expansion, the greater thestiffness of the object is. The material and/or the surface structure ofthe expandable portion may e.g. have the characteristic that it from acertain degree of expansion has the required stiffness and may befurther expanded up to full expansion while maintaining the same, orsubstantially the same, stiffness. Another way of achieving thecharacteristic that the penile implant has the required stiffness tomake the penis erect and hard also when the penile implant is in apartly expanded state will now be described. It is assumed that thepenile implant comprises a hollow part adapted to be filled with afluid, the hollow part may be realized in that the penile implant itselfis hollow or it may comprise a hollow body. The hollow part is dividedin compartments separated by dividing wall(s) having a valve which at afirst side opens for fluid flow from the first side when the fluidpressure at the first side exceeds a certain pressure value butotherwise is closed for fluid flow from the first side. At the secondside of the valve the valve opens for fluid flow from the second sidealready when the fluid pressure at the second side is very low, suitablyat substantially zero pressure. This to enable emptying the compartmenton the second side and collapsing an invagination, the compartment onthe second side of the wall has at least one invagination. In this way afirst compartment on the first side of a dividing wall can be filled andpressurized with fluid to make the implant hard and stiff at a firstsize, and by further increasing the pressure of the fluid a secondcompartment on the second side of a dividing wall can be filled andpressurized with fluid to make the implant hard and stiff at a second,greater size when the invagination bulge due to the fluid pressure.Suitably the first compartment is adapted to always be filled andpressurized with fluid when the implant is activated. Of course morethan two compartments may be used where dividing walls separate thedifferent compartments and where the valves in the different dividingwalls have increasing pressure thresholds starting with a first valve ina first dividing valve between the first and the second compartmenthaving the lowest threshold. In this way it can be achieved that whensuch an implant is implanted in the corpus cavernosum, suitably oneimplant in each corpus cavernosum, the implant(s) can be activated insteps to make the penis erect and hard at several different sizes of thepenis, both regarding diameter and length.

The invagination of the second compartment may also e.g. be a bendingportion which makes it possible to selectively activate, or to differentdegrees activate, the bending portion. There may also be several suchbending portions located around the circumference of the penile implant,this makes it possible to selectively activate different bendingportions to achieve an erected penis that is bent not only upwards butalso to either side or downwards, if this should be desired.

With a penile implant of any of the designs described above, it is assaid possible to achieve that the penile implant, or implants sincenormally one penile implant is placed in each corpus cavernosum, can beactivated to make the penis erect and hard at different sizes of thepenis, e.g. at sizes from 60% to 100% or from 80% to 100% of the maximumsize of the penis. The maximum size of the penis corresponds to thestate when the at least one implant, placed in the corpus cavernosum ofthe penis, is fully expanded.

Generally, suitably the penile implant comprises a radially expandableportion and/or a longitudinally expandable portion to enable anenlargement and/or an elongation or extension of the penis when thepenile implant is placed in the corpus cavernosum and activated and/orexpanded. Said sections may each comprise a bellows structure,respectively a radial and a longitudinal bellows structure. Saidexpandable portions may have different surface structures and/or crosssections.

The radially expandable portion may e.g. be realized or implemented bydesigning the penile implant with a waist so that the cross section ofthe penile implant comprises two concavenesses or indentations which maybe located substantially opposite each other. The implant, and hencealso the cross section of the implant, may also comprise more than twoconcavenesses or indentations, e.g. four concavenesses or indentations,which may be located substantially equally spaced around thecircumference of the implant. The penile implant may also comprise oneconcaveness or indentation where it is suitable that the penile implantis placed in the corpus cavernosum so that the opening of theconcaveness or indentation faces, or substantially faces, the urethra.The at least one concaveness or indentation may e.g. be substantiallyU-shaped or V-shaped in cross section and suitably has a rounded shapewithout sharp edges. Hence, the radial bellows structure comprises thementioned waist and/or concaveness(es) or indentation(s).

The longitudinally expandable portion may comprise a longitudinalbellows structure having a substantially saw tooth shaped surface. Theridges and grooves of the longitudinal bellows structure also may have asubstantially square shape so that the longitudinal bellows structurecomprises a square wave shaped surface. The ridges and grooves of thelongitudinal bellows structure may also be rounded to different degreesso that the longitudinal bellows structure comprises a more or less waveshaped surface. The surface shape(s) of the longitudinally expandableportion may extend along a part of, parts of, or the complete,circumference of the implant. In the case of a surface shape comprisingridges and grooves, it is suitable that the ridges and grooves extend ina substantially circumferential direction of the penile implant and thatthe ridges and grooves are placed alternating one after the other in asubstantially longitudinal direction of the implant.

In general, both the radially expandable portion and the longitudinallyexpandable portion may comprise any suitable surface shape which enablesan appropriate function of the section(s), e.g. any of the surfaceshapes or elements described in the section of this applicationregarding the surface structure having elevated and lowered areas.

The radially expandable portion is suitably located on the part of thepenile implant that is adapted to be placed in the protruding orpendulous part of the penis. The longitudinally expandable portion maybe located on the part of the penile implant that is adapted to beplaced in the part of the penis that substantially extends on the insideof the body, also called the root of the penis, and/or on the part ofthe penile implant that is adapted to be placed in the protruding orpendulous part of the penis. The penile implant may suitably comprise arelatively short proximal portion and a flexible relatively long distalportion. Suitably the proximal portion is to be anchored or located inthe root of the penis and the distal portion is to be located in or toextend along the pendulous part of the penis. The radially and thelongitudinally expandable portion may also be located to partly overlapeach other. Both sections may e.g. be located on the distal portion, thelongitudinally expandable portion suitably on the part of the distalportion which is in the vicinity of the position where the proximal anddistal portion meet, and the radially expandable portion suitably extendalong substantially the whole distal portion. Depending on the desiredshape of the penis when the penile implant is in an expanded state theradially expandable portion may also extend along only a part of thedistal portion. The part of the penile implant that is adapted to beplaced in the vicinity of or at the position of the glans penis may e.g.have no radially expandable portion or a radially expandable portionwith smaller or greater possible radial expansion than the rest of theradially expandable portion.

The longitudinal extension of the longitudinally expandable portion whenthe penile implant is in its collapsed state is suitably in the intervalof around 5-100 mm, depending on the circumstances, e.g. the desiredpossible prolongation or extension when the penile implant is expandedand the length of the penile implant in its collapsed state. It may besuitable that the longitudinally expandable portion has a longitudinalextension that is around 10 to 40 percent of the total longitudinalextension of the penile implant. The depth of the bellows structure ofthe longitudinally expandable portion when the penile implant is in itscollapsed state is suitably in the interval of around 0.5 to 5 mm, evenmore suitable around 1-4 mm and most suitably around 1.5-3 mm, dependingon the circumstances, e.g. the desired possible prolongation orextension when the penile implant is expanded and the length of thepenile implant. For measuring the depth of a bellows structure one maymeasure the distance between the bottom of a groove and the top of aridge.

The longitudinal extension of the radially expandable portion has beendiscussed above. When the penile implant is in its collapsed state asuitable interval for the longitudinal extension of the radiallyexpandable portion is around 5-250 mm, depending on the circumstances,e.g. the length of the distal part of the penile implant in itscollapsed state. It may be suitable that the radially expandable portionhas a longitudinal extension that is around 80 to 100 percent of thetotal longitudinal extension of the distal part of the penile implant.The total depth or extension of the concavenesses or indentations of theradially expandable portion when the penile implant is in its collapsedstate is suitably in the interval of around 5 to 70 mm, depending on thecircumstances, e.g. the desired diameter of the penile implant in thecollapsed state and in an expanded state. It may be suitable that thetotal depth or extension of the concavenesses or indentations of theradially expandable portion is around 40 to 60 percent of thecircumference of the penile implant in its collapsed state when notincluding the extension of the concavenesses or indentations whencalculating the circumference.

According to yet another aspect of the invention there is provided animplantable vibration device adapted to improve or remedy dysfunctionalejaculation. Suitably the vibration device is adapted to be implanted inthe genital area, e.g. in the corpus cavernosum of a penis of a personor in a penile implant for curing erectile impotence or in a penileprosthesis system for curing erectile impotence. The vibration device islocated so as to cause a vibration to improve or remedy dysfunctionalejaculation.

The vibration device may fully or partly remedy dysfunctionalejaculation. If the vibration device is located in a penile implant orpenile prosthesis system for curing erectile impotence, which is filledwith a transportable medium, e.g. a fluid, the vibration device may beplaced in the transportable medium. In this way the vibrations from thevibration device can be conveyed from the vibration device to the penileimplant or penile prosthesis system via the transportable medium. Inthis case the vibration device may be placed either in the penileimplant or in an element containing transportable medium and beingconnected to the penile implant. Such an element may e.g. be areservoir, a conduit or a pump. Hence, there is also provided a penileimplant and a penile prosthesis system comprising a vibration device.Generally the vibration device is adapted and located so as to stimulateat least a part of the sexually responsive tissue of the penis of thepatient or person.

The vibration device may be of any suitable known type, e.g. a motorhaving an eccentric element eccentrically mounted to its axis, avibration device of the magnetic type using magnetic repulsion and/orattraction, a piezoelectric device or a vibration device having areciprocating piston. Suitably the vibration device is adapted to createmovement with a frequency of around 0.1 to 10 000 Hz, and to createmovement with an amplitude of around 0.01 to 30 mm.

Suitably the penile implant or implantable device comprises at least onehollow section or hollow body in all of the described aspects. The atleast one hollow section or hollow body may be expandable and/orcollapsible and may extend along the whole length, or part of thelength, of the implantable device.

The implantable device may also comprise a transportable medium adaptedto be received into the at least one hollow section or hollow body, orto be withdrawn from the at least one hollow section or hollow body, inorder to activate respectively inactivate the implantable device.

The at least one hollow section or hollow body may suitably be adaptedto receive the transportable medium, and adapted so that thetransportable medium can be withdrawn from the hollow section or hollowbody, in order to activate respectively inactivate the implantabledevice.

The implantable device may be placed in the corpus cavernosum by anysuitable known technique, e.g. by surgically forming a passageway in thecorpus cavernosum and then placing or locating the implantable device inthe passageway.

According to yet a further aspect of the invention there is provided apenile prosthesis system for curing erectile impotence where the systemcomprises at least one penile implant or penile implantable device asdescribed herein. Suitably the system comprises two penile implants orpenile implantable devices. Such a system suitably includes an operationdevice connected, suitably by a conduit, to the at least one penileimplantable device. The operation device may comprise a fluid reservoirand a pump both connected to the at least one penile implantable deviceby a conduit so that fluid can be pumped to and from the penileimplantable device(s). The pump may be manually operated or powered byan energy source. The system may as well comprise a control deviceconnected to the operation device, suitably to the pump but it may aswell be connected to the fluid reservoir. The control device maytransmit control signals and/or powering signals to the pump and/or thefluid reservoir.

In the text describing the system, e.g. a penile prosthesis system, itis stated that different parts is or are for operating or regulating thepenile implant or penile implantable device. This implies e.g. thatthese different parts are adapted to fill and pressurize the penileimplantable device and mentioned parts of the penile implantable devicewith a transportable medium, e.g. a fluid. This implies e.g. also thatthese different parts are adapted to withdraw a transportable medium,e.g. a fluid, from the penile implantable device and mentioned parts ofthe penile implantable device. Mentioned parts of the penile implantabledevice are e.g. the expandable section, the pre-formed section, thebending portion, the radially expandable portion, the longitudinallyexpandable portion, the first and second compartments, the first andsecond hollow portions and the hollow body.

According to yet another aspect of the invention there is provided amethod for invasively placing said penile implantable device in thecorpus cavernosum of a penis.

As mentioned, said penile implantable device may suitably be a penileimplant or penile prosthesis for curing erectile impotence and adaptedto be implanted in the corpus cavernosum of a penis.

The described aspects and features may be freely combined with anotherand thereby an implantable device or implantable vibration device havingadvantages from the combined aspects and features can be achieved. Bycombining the described aspects and features additional, synergisticeffects can also be achieved. The described surface structure in itsdifferent embodiments may e.g. be used in any of the other aspects ofthe invention whereby additional advantages can be obtained. For examplemay the pre-formed section, the bending portion and the radially andlongitudinally expandable portions comprise any of the elements,features and embodiments of the surface structure. Further may forexample a penile implant comprise a pre-formed section and/or a bendingportion and/or a radially and a longitudinally expandable portion. Theimplantable vibration device may as well be combined with theimplantable device and the penile prosthesis system.

The invention may also be described as in the following.

A penile implant (10), in particular a penile implant for curingimpotence, wherein said penile implant (10) is adapted to be implantedin the corpus cavernosum of a penis.

According to one aspect there is provided a penile implant, inparticular a penile implant for curing erectile impotence. The penileimplant may be adapted to be implanted in the corpus cavernosum of apenis, may be adapted to post-operatively be adjustable and may compriseat least one expandable section. The penile implant may be adapted to beadjustable between a first collapsed state, in which the expandablesection is collapsed, and a second expanded state, in which theexpandable section is expanded.

The outer surface of said expandable section may at least partlycomprise a surface structure having elevated areas alternating withlowered areas.

Said expandable section may be adapted to have, in at least one of saidfirst collapsed and second expanded states,

a first distance between adjacent elevated areas which distance issufficiently extended to prevent growth of fibrotic tissue from directlyinterconnecting adjacent elevated areas to an extent that compromisesthe adjustability between a first collapsed and a second expanded stateof said penile implant.

The surface structure may further comprise connecting areas betweenadjacent elevated and lowered areas. The connecting areas may further beadapted to have, in at least one of said first collapsed and secondexpanded states,

a second distance between adjacent connecting areas which distance issufficiently extended to prevent growth of fibrotic tissue from directlyinterconnecting adjacent connecting areas to an extent that compromisesthe adjustability between a first collapsed and a second expanded stateof said penile implant.

The penile implant may optionally have the following furthercharacteristics:

According to one embodiment there is provided a penile implant which isadapted to be non-invasively adjustable.

According to another embodiment there is provided a penile implantwherein at least said expandable section, is hollow or comprises ahollow body.

According to a further embodiment there is provided a penile implantwherein said penile implant is substantially completely hollow orcomprises a hollow body extending along substantially the completelength of said penile implant.

According to yet another embodiment there is provided a penile implantwherein said penile implant comprises a transportable medium, e.g. afluid. The transportable medium may be adapted to be received into andpressurize said expandable section and/or said penile implant and/orsaid hollow body, to bring said penile implant into said second expandedstate. The transportable medium may further be adapted to be withdrawnfrom said expandable section and/or said penile implant and/or saidhollow body, to bring said penile implant into said first collapsedstate.

According to yet a further embodiment there is provided a penile implantwherein said expandable section and/or said penile implant and/or saidhollow body, is adapted to receive, and be pressurized by, a fluid tobring said penile implant (10) into said second expanded state. Furthermay said expandable section and/or said penile implant and/or saidhollow body be adapted to release said fluid, or adapted so that saidfluid may be withdrawn therefrom, to bring said penile implant into saidfirst collapsed state.

According to one embodiment there is provided a penile implant whereinsaid first respectively said second distance is adapted to fulfill saidcondition of preventing fibrotic tissue from directly connectingadjacent areas when said penile implant is in its first collapsed state.

According to another embodiment there is provided a penile implantwherein said first respectively said second distance is adapted tofulfill said condition of preventing fibrotic tissue from directlyconnecting adjacent areas, when said penile implant is in its secondexpanded state.

According to a further embodiment there is provided a penile implantwherein the outer surface of said expandable section is at least partlysubstantially bellows shaped or substantially corrugated.

According to yet another embodiment there is provided a penile implantwherein said penile implant, seen in cross section, comprises a waistportion.

According to yet a further embodiment there is provided a penile implantwherein the lowered areas lie in a plane substantially in parallel to aplane of the elevated areas.

According to one embodiment there is provided a penile implant whereinthe outer surface of said expandable section at least partly comprisesridges and grooves.

According to another embodiment there is provided a penile implantwherein said ridges and grooves are substantially parallel.

According to a further embodiment there is provided a penile implantwherein the outer surface of said expandable section at least partlycomprises protrusions and depressions.

According to yet another embodiment there is provided a penile implantwherein the top surfaces of the ridges and/or the bottom surfaces of thegrooves at least partly have an extension greater than 1 mm in adirection transversal to the longitudinal direction of the ridges and/orgrooves.

According to yet a further embodiment there is provided a penile implantwherein the distance between a plane of an elevated area and a plane ofa lowered area is larger than 1 mm to facilitate achieving said firstcollapsed and/or said second expanded state.

According to one embodiment there is provided a penile implant whereinsaid expandable section is preformed into a shape substantiallycorresponding to the shape assumed by said penile implant in its firstcollapsed state.

According to another embodiment there is provided a penile implantwherein said alternating elevated areas and lowered areas aredistributed over said outside surface of said penile implant so as tofacilitate said penile implant assuming a specific shape when expanded.

According to a further embodiment there is provided a penile implantwherein said alternating elevated areas and lowered areas cover a largerpart of one side of said penile implant, than of the opposite side ofsaid penile implant.

According to another aspect there is provided a penile implant, inparticular a penile implant for curing erectile impotence, wherein saidpenile implant is adapted to be implanted in the corpus cavernosum of apenis. Further may said penile implant be adapted to be post-operativelyadjustable. Said penile implant may comprise a pre-formed section whichis positioned at a point or in an area of said penile implant which isin the vicinity of and/or includes the position where the protrudingpart of the penis starts. Said preformed section is formed in such a waythat bending creases are avoided or reduced when said penile implant isimplanted and the penis is in a relaxed or flaccid position, suitablyhanging in a relaxed or flaccid position.

The penile implant may optionally have the following furthercharacteristics:

According to one embodiment there is provided a penile implant whereinsaid pre-formed section comprises at least one fold, pleat, bellowshaped part or part having a smooth surface, or combinations thereof.Said pre-formed section may have a longitudinal extension in theinterval of around 1 to 100 mm.

According to another embodiment there is provided a penile implantwherein said pre-formed section is expandable.

According to a further embodiment there is provided a penile implantwhich is adapted to be non-invasively adjustable.

According to yet another embodiment there is provided a penile implantwherein said penile implant is adapted to selectively assume a firstin-activated state, in which said penile implant may be collapsed, and asecond activated state, in which said penile implant may be expanded.

According to yet a further embodiment there is provided a penile implantwherein at least said pre-formed section is hollow or comprises a hollowbody.

According to one embodiment there is provided a penile implant whereinsaid penile implant is substantially completely hollow or comprises ahollow body extending along substantially the complete length of saidpenile implant.

According to another embodiment there is provided a penile implant whichmay comprise a transportable medium, e.g. a fluid. The transportablemedium is adapted to be received into and pressurize said pre-formedsection and/or said penile implant and/or said hollow body, to bringsaid penile implant into said second activated state. The transportablemedium may as well be adapted to be withdrawn from said pre-formedsection and/or said penile implant and/or said hollow body, to bringsaid penile implant into said first in-activated state.

According to a further embodiment there is provided a penile implantwherein said pre-formed section and/or said penile implant and/or saidhollow body, is adapted to receive, and be pressurized by, a fluid tobring said penile implant (10) into said second activated state. Furthersaid pre-formed section and/or said penile implant and/or said hollowbody may be adapted to release said fluid, or adapted so that said fluidmay be withdrawn therefrom, to bring said penile implant into said firstin-activated state.

According to a further aspect there is provided a penile implant, inparticular a penile implant for curing erectile impotence, wherein saidpenile implant may be adapted to be implanted in the corpus cavernosumof a penis of a person. Further may said penile implant be adapted to bepost-operatively adjustable.

Said penile implant may as well be adapted to selectively assume anin-activated state whereby said penis can be made flaccid, and anactivated state whereby said penis can be erected or made erected.

Said penile implant may be collapsed in its in-activated state andexpanded in its activated state.

Said penile implant may have a relatively short proximal portion whichis suited to be placed or located in the root of the penis, and aflexible relatively long distal portion, which is suited to be placed soas to extend along or to be located in the pendulous or protruding partof the penis.

Said penile implant may further comprise a bending portion placed orlocated between the proximal and the distal portion, or in the vicinityof the position where the proximal and the distal portion meet.

Said bending portion may be adapted to enable said penile implant, whensaid penile implant is implanted and activated, to bring at least thependulous or protruding portion of the penis to a position in which thepenis has an acute angle with the vertical plane when said person isstanding. That is, a position in which at least the pendulous orprotruding portion of the penis is upwardly bent when said person isstanding.

The penile implant may optionally have the following furthercharacteristics:

According to one embodiment there is provided a penile implant whereinsaid bending portion may comprise a pliable or elastic wall part of saidpenile implant. Said wall part extends along a part of, along parts of,or along the complete, circumference of said penile implant. Said wallpart extends in such a way as to, when said penile implant is implantedand activated, bring at least the pendulous part of the penis to aposition in which the penis has an acute angle with the vertical planewhen said person is standing.

According to another embodiment there is provided a penile implantwherein said wall part extends along at least a part of the underside,and along at least a part of the upper side of said penile implant. Saidwall part has a greater longitudinal extension on the underside than onthe upper side of said penile implant (10), when said penile implant(10) is activated and/or inactivated. This in order to, when said penileimplant is implanted and activated, bring at least the pendulous part ofthe penis to a position in which the penis has an acute angle with thevertical plane when said person is standing.

According to another embodiment there is provided a penile implantcomprising a bending portion placed or located between the proximal anddistal portion, or in the vicinity of the position where the proximaland distal portion meet, said bending portion being adapted to enablesaid penile implant, when said penile implant is implanted andactivated, to bring at least the pendulous or protruding portion of thepenis to a position in which the penis has an acute angle with thevertical plane when said person is standing, that is, a position inwhich at least the pendulous or protruding portion of the penis isupwardly bent when said person is standing, and in which position thedistal portion is more upwardly oriented than the proximal portion.

According to a further embodiment there is provided a penile implantwherein said bending portion comprises a bellows structure which extendsalong a part of, along parts of, or along the complete, circumference ofsaid penile implant. Said bellows structure is designed so that at leastpart of the underside of said penile implant shows a greater lengthexpansion when said penile implant is activated than the upper side ofsaid penile implant. This in order to, to, when said penile implant isimplanted and activated, bring at least the pendulous part of the penisto a position in which the penis has an acute angle with the verticalplane when said person is standing.

According to yet another embodiment there is provided a penile implantwherein said bellows structure extends along at least a part of theunderside, and along at least a part of the upper side of said penileimplant.

Said bellows structure may have a greater longitudinal extension on theunderside than on the upper side of said penile implant. Further maysaid bellows structure have a greater depth, at least when said penileimplant is in it's in- or non-activated state, on the underside than onthe upper side of said penile implant.

This in order to, when said penile implant is implanted and activated,bring at least the pendulous part of the penis to a position in whichthe penis has an acute angle with the vertical plane when said person isstanding.

According to one embodiment there is provided a penile implant whereinsaid bending portion is positioned at a point or in an area of saidpenile implant which is in the vicinity of and/or including the positionwhere the pendulous or protruding part of the penis starts.

According to another embodiment there is provided a penile implantwherein said bending portion is positioned at or on said proximalportion, suitably in the vicinity of the position where said proximalportion and said distal portion meet.

According to a further embodiment there is provided a penile implantwhich is adapted to be non-invasively adjustable.

According to yet another embodiment there is provided a penile implantwherein at least said bending portion is hollow or comprises a hollowbody.

According to yet a further embodiment there is provided a penile implantwhich is substantially completely hollow or comprises a hollow bodyextending along substantially the complete length of said penileimplant.

According to one embodiment there is provided a penile implant whichcomprises a transportable medium, e.g. a fluid. Said transportablemedium is adapted to be received into and pressurize said bendingportion and/or said penile implant and/or said hollow body in order tobring said penile implant into said second activated state. Saidtransportable medium may as well be adapted to be withdrawn from saidbending portion and/or said penile implant and/or said hollow body, tobring said penile implant into said first in-activated state.

According to another embodiment there is provided a penile implantwherein said bending portion and/or said penile implant and/or saidhollow body, is adapted to receive, and be pressurized by, a fluid tobring said penile implant into said second activated state. Further maysaid bending portion and/or said penile implant and/or said hollow bodybe adapted to release said fluid, or adapted so that said fluid may bewithdrawn therefrom, to bring said penile implant into said firstin-activated state.

According to a further embodiment there is provided a penile implantwherein said bending portion comprises that said proximal portion has apliable top wall and a pliable bottom wall. Said bottom wall is designedto longitudinally distend more than said top wall, when said penileimplant is brought into said second activated state by saidtransportable medium. This in order to cause said distal portion to bendupwardly in relation to said proximal portion.

According to yet another embodiment there is provided a penile implantwherein said bottom wall of said proximal portion formscircumferentially extending alternating ridges and grooves. Said bottomwall thereby behaves like an expanding bellows when said penile implantis brought into said second activated state by said transportablemedium.

According to yet a further embodiment there is provided a penile implantwherein said ridges of said bottom wall are spaced apart from oneanother, when said penile implant is in its inactivated state.

According to one embodiment there is provided a penile implant whereinsaid top wall forms circumferentially extending alternating ridges andgrooves. These ridges and grooves are dimensioned such that said topwall longitudinally distends less than said bottom wall, when saidpenile implant is brought into said second activated state by saidtransportable medium.

According to another embodiment there is provided a penile implantwherein said grooves are wedge-shaped.

According to a further embodiment there is provided a penile implantwherein said ridges have a polygonal cross-section.

According to yet another embodiment there is provided a penile implantwherein said distal portion of said penile implant comprisescircumferentially extending alternating ridges and grooves. Thereby saiddistal portion behaves like an expanding bellows and longitudinallyprolongs, when said penile implant is brought into said second activatedstate by said transportable medium.

According to yet a further embodiment there is provided a penile implantwherein said proximal portion of said penile implant is made of anelastic material.

According to one embodiment there is provided a penile implant whereinsaid top wall of said proximal portion is substantially thicker thansaid bottom wall of said proximal portion.

According to a further embodiment there is provided a penile implantwherein said elastic material comprises silicone elastomer.

According to yet another aspect there is provided a penile implant, inparticular a penile implant for curing erectile impotence. Said penileimplant may be adapted to be implanted in the corpus cavernosum of apenis of a person. Said penile implant is at least partly hollow and/orat least partly comprises a hollow body. Said penile implant comprises afoam material transparent for fluid, said foam material is at leastpartly filling said penile implant and/or said hollow body.

Suitably said foam material has a lower density than water. Said penileimplant and/or said hollow body is adapted to be filled with said foammaterial and said fluid so that said foam material and said fluidtogether substantially fill the volume of said penile implant and/orsaid hollow body.

According to one embodiment, there is provided a penile implant adaptedto be implanted in the corpus cavernosum of a penis of a person, wheresaid penile implant is preferably at least partly hollow and/or at leastpartly comprises a hollow body, said penile implant preferablycomprising a foam material transparent for fluid, said foam materialfilling the hollow part of said penile implant and/or said hollow bodyin a first inactivated state where the penis is in a flaccid state, andwherein said foam material has a lower density than water, and whereinsaid foam material being transparent for fluid and filling the hollowpart of said penile implant and/or said hollow body is adapted to befilled with a fluid in a second activated state, which fluid in saidsecond activated state creates an penile erection, to togethersubstantially fill the volume of the hollow part of said penile implantand/or said hollow body.

According to one embodiment, there is provided a penile implant, whereinthe outer surface of said foam material being transparent for fluid isintegrated in the surface delimiting the hollow part of said penileimplant and/or said hollow body.

According to one embodiment, there is provided a penile implant whereinsaid penile implant is adapted to be implanted in the corpus cavernosumof a penis of a person, and

wherein said penile implant at least partly is hollow and/or at leastpartly comprises a hollow body, said penile implant comprising closedspaces, suitably bubbles, which contain, or are filled with, a solidmaterial, a gas or a fluid, e.g. air or foam material, said closedspaces being arranged at the surface delimiting the hollow part of saidpenile implant and/or said hollow body, and

wherein the hollow part of said penile implant and/or said hollow bodyis adapted to be filled with a fluid in a second activated state, whichfluid in said second activated state creates an penile erection.

According to one embodiment, there is provided a penile implant whereinsaid fluid is adapted to be received into and pressurize said penileimplant and/or said hollow body, to bring said penile implant into saidsecond activated state, or to be withdrawn from said penile implantand/or said hollow body, to bring said penile implant into said firstin-activated flaccid state.

According to one embodiment, there is provided a penile implant whereinthe hollow space arranged for receiving the fluid in said penile implantis arranged longitudinally along the penile implant.

According to one embodiment, there is provided a penile implant whereinsaid closed spaces being arranged at the surface delimiting the hollowpart of said penile implant and/or said hollow body are arranged in abody integrated with the outer part of said penile implant where saidbody and said outer part of said penile implant are made of differentmaterials.

In any of the embodiments where foam material fills the hollow part ofsaid penile implant and/or said hollow body in a first inactivated statewhere the penis is in a flaccid state, it is possible that said penileimplant and said foam material, are: arranged integrated, attached toeach other by using e.g. adhesive or glue, molded in one piece, made ofsame material, or made of different material.

In any of the embodiments where said penile implant comprises closedspaces, suitably bubbles, which contain, or are filled with, a solidmaterial, a gas or a fluid, e.g. air or foam material, said closedspaces being arranged at the surface delimiting the hollow part of saidpenile implant and/or said hollow body, it is possible that said penileimplant and said body comprising the closed spaces, are: arrangedintegrated, attached to each other by using e.g. adhesive or glue,molded in one piece, made of same material, or made of differentmaterial.

The penile implant may optionally have the following furthercharacteristics.

According to one embodiment there is provided a penile implant whereinsaid foam material comprises open spaces that can be filled with saidfluid.

According to another embodiment there is provided a penile implantwherein said foam material is a closed cellular foam material whichcomprises closed spaces, suitably bubbles. The closed spaces maycontain, or may be filled with, a solid material, a gas or a fluid, e.g.air or foam material.

According to a further embodiment there is provided a penile implantwherein said penile implant is adapted to be non-invasively adjustable.

According to yet another embodiment there is provided a penile implant,which is adapted to selectively assume a first in-activated state,wherein said penile implant may be collapsed, and a second activatedstate, wherein said penile implant may be expanded.

According to yet a further embodiment there is provided a penile implantwherein said fluid is adapted to be received into and pressurize saidpenile implant and/or said hollow body, to bring said penile implantinto said second activated state. Said fluid may also be adapted to bewithdrawn from said penile implant and/or said hollow body, to bringsaid penile implant into said first in-activated state.

According to one embodiment there is provided a penile implant whereinsaid penile implant and/or said hollow body, is adapted to receive, andbe pressurized by, a fluid to bring said penile implant (10) into saidsecond activated state. Said penile implant and/or said hollow body mayalso be adapted to release said fluid, or adapted so that said fluid maybe withdrawn, to bring said penile implant into said first in-activatedstate.

According to yet a further aspect there is provided a penile implant,which may be a penile implant for curing erectile impotence. Said penileimplant may be elongated and may be adapted to be implanted in thecorpus cavernosum of a penis of a person. Said penile implant may alsobe adapted to post-operatively be adjustable.

Said penile implant may comprise at least one expandable portion and isadjustable between a first collapsed state and at least one other,partly or fully expanded, state. In the collapsed state the at least oneexpandable portion is collapsed, and in the other, partly or fullyexpanded, state said at least one expandable portion is partly or fullyexpanded.

Said at least one expandable portion may comprise at least one itemchosen from the group consisting of; a radially expandable portion, aradially expandable segment, a longitudinally expandable portion, and alongitudinally expandable segment.

Said penile implant may have a predetermined shape with a length and adiameter and may be adapted to allow an increase of the penile implantdiameter and/or length when being adjusted from said first collapsed tosaid at least one partly or fully expanded state. This in order toachieve penile erection with increased penile diameter and/or lengthwhen said penile implant is implanted and partly or fully expanded, ascompared to a relaxed status of the penis.

According to yet another aspect there is provided a penile implant,which may be a penile implant for curing erectile impotence. Said penileimplant may be elongated and may be adapted to be implanted in thecorpus cavernosum of a penis of a person. Said penile implant may beadapted to post-operatively be adjustable.

Said penile implant may comprise at least one expandable portion and maybe adjustable between a first in-activated or collapsed state and atleast one other, partly or fully expanded, activated state. In the firststate said at least one expandable portion is collapsed and in theother, activated state, said at least one expandable portion is partlyor fully expanded.

Said at least one expandable portion may comprise a radially expandableportion and/or a radially expandable segment at least partly comprisinga cross section presenting at least one concaveness or indentation. Saidcross section may present a concaveness or indentation facing theurethra of the penis.

Said penile implant may have a predetermined shape with a length and adiameter and may be adapted to allow an increase of the penile implantdiameter when being adjusted from said first in-activated or collapsedstate to said at least one other, partly or fully expanded, activatedstate. This in order to achieve penile erection with increased penilediameter when said penile implant is implanted and partly or fullyexpanded, as compared to a relaxed status of the penis.

The penile implant may optionally have the following furthercharacteristics.

According to one embodiment there is provided a penile implant whereinsaid radially expandable portion or said radially expandable segment atleast partly comprises a cross section presenting at least oneconcaveness or indentation.

According to another embodiment there is provided a penile implantwherein said cross section presents at least two concavenesses orindentations.

According to a further embodiment there is provided a penile implantwherein said cross section presents a concaveness or indentation facingthe urethra.

According to yet another embodiment there is provided a penile implantwhich comprises said radially expandable portion or said radiallyexpandable segment on the part of said penile implant that is adapted tobe placed in the protruding or pendulous part of the penis.

According to yet a further embodiment there is provided a penile implantwherein said at least one expandable portion comprises a longitudinallyexpandable portion or a longitudinally expandable segment. Thelongitudinally expandable portion or the longitudinally expandablesegment may comprise a longitudinally expandable structure thatcomprises at least one concaveness or indentation.

According to one embodiment there is provided a penile implant whereinsaid at least one expandable portion comprises a longitudinallyexpandable portion or a longitudinally expandable segment. Thelongitudinally expandable portion or the longitudinally expandablesegment may comprise a longitudinal bellows structure that comprisesridges and grooves that extend substantially circumferentially along apart of, along parts of, or along the complete, circumference of saidpenile implant.

According to another embodiment there is provided a penile implantwherein said longitudinally expandable portion or said longitudinallyexpandable segment is present on a proximal part of said penile implant.The proximal part may be adapted to be placed in the root part of thepenis. The root part of the penis extends substantially on the inside ofthe body.

According to a further embodiment there is provided a penile implantwherein said longitudinally expandable portion or said longitudinallyexpandable segment is present on a distal part of said penile implant.Said distal part in suitably adapted to be placed in the protruding orpendulous part of the penis.

According to one embodiment there is provided a penile implant wherein;

the distance between the substantially opposing sides of the at leastone concaveness or indentation,

and/or

the distance between the substantially opposing sides of the ridges andgrooves of the longitudinal bellows structure,

is sufficiently extended to prevent growth of fibrotic tissue fromdirectly interconnecting said substantially opposing sides to an extentthat compromises the adjustability between a first collapsed state andat least one other, partly or fully expanded, state.

According to another embodiment there is provided a penile implantwherein;

the distance between the substantially opposing sides of the at leastone concaveness or indentation,

and/or

the distance between the substantially opposing sides of the ridges andgrooves of the longitudinal bellows structure,

is greater than around 1 mm, greater than around 2 mm, or greater thanaround 3 mm.

According to yet another embodiment there is provided a penile implantwhich is adapted to be non-invasively adjustable.

According to a further embodiment there is provided a penile implantwherein at least said at least one expandable portion is hollow orcomprises a hollow body.

According to yet a further embodiment there is provided a penile implantwherein said penile implant is substantially completely hollow orcomprises a hollow body extending along substantially the completelength of said penile implant.

According to one embodiment there is provided a penile implant whereinsaid penile implant comprises a transportable medium, e.g. a fluid. Thetransportable medium may be adapted to be received into and pressurizesaid at least one expandable portion and/or said penile implant and/orsaid hollow body. This in order to bring said penile implant into saidat least one partly or fully expanded state. The transportable mediummay also be adapted to be withdrawn from said at least one expandableportion and/or said penile implant and/or said hollow body, to bringsaid penile implant (10) into said first collapsed state.

According to another embodiment there is provided a penile implantwherein said at least one expandable portion and/or said penile implantand/or said hollow body, is adapted to receive, and to be pressurizedby, a fluid. This in order to bring said penile implant into said atleast one partly or fully expanded state. Said at least one expandableportion and/or said penile implant and/or said hollow body may also beadapted to release said fluid, or adapted so that said fluid may bewithdrawn, to bring said penile implant into said first collapsed state.

According to a further embodiment there is provided a penile implantwherein said penile implant or said hollow body comprises a first and atleast one second compartment both being adapted to be filled andpressurized with a fluid. The first and the at least one secondcompartment are separated by at least one dividing wall having at leastone valve.

Said radially expandable segment and said longitudinally expandablesegment may each comprise at least one of; a second compartment, adividing wall having at least one valve, at least one invagination.

Said at least one second compartment comprises at least oneinvagination. Said at least one valve suitably has a first side or facewhich is adapted to be closed for fluid up to a predetermined fluidpressure threshold. For fluid pressures above said fluid pressurethreshold said at least one valve is adapted to open. Said at least onevalve suitably also has a second side or face which is adapted to beopen for fluid at substantially any pressure, at least for a pressuregreater than zero.

Said at least one invagination is adapted to bulge when subjected tofluid pressure and to resume its invaginated form when said fluidpressure is removed.

According to yet a further embodiment there is provided a penile implantwherein said first compartment is adapted to be connected to a source ofpressurized fluid.

Said first side or face of said at least one valve is suitably facingsaid first compartment and said second side or face of said at least onevalve is suitably facing said at least one second compartment. This isin order to enable that said at least one second compartment can befilled and pressurized with fluid when the fluid pressure in said firstcompartment exceeds said fluid pressure threshold so that said at leastone invagination bulges and hence prolongs or radially expands saidpenile implant and/or hollow body.

According to yet another embodiment there is provided a penile implantwherein said penile implant or said hollow body comprises alongitudinally expandable portion having a first and a second hollowportion. The first and the second hollow portion are each adapted to befilled and pressurized with a fluid, they may be connected by an elasticfirst conduit, and optionally also by an elastic second conduit. Thefirst and the second hollow portion may as well be connected by anelastic connecting portion.

At least one of, and suitably each of, said first and second hollowportions comprises at least one invagination. Said invagination issuitably adapted to bulge when subjected to fluid pressure and to resumeits invaginated form when said fluid pressure is removed.

According to one embodiment there is provided a penile implant whereineach of said first and second hollow portions comprises an invagination.Said invaginations are suitably facing each other and are adapted tobulge and mutually exert a force on each other when subjected to fluidpressure. This in order to prolong said penile implant and/or hollowbody when said first and second hollow portions are filled andpressurized with a fluid. Said invaginations are suitably adapted toresume their invaginated form when said fluid pressure is removed sothat said penile implant and/or hollow body resumes its not prolongedlength.

In another aspect there is provided a surgery method where a penileimplant as described above is implanted in the patient.

In a further aspect there is provided a system that comprises a penileimplant as described above.

In one embodiment the system comprises at least one switch implantablein the patient for manually and non-invasively controlling the penileimplant.

In one embodiment the system comprises a hydraulic device having animplantable hydraulic reservoir, which is hydraulically connected to thepenile implant, wherein the penile implant is adapted to benon-invasively regulated by manually pressing the hydraulic reservoir.

In one embodiment the system comprises a wireless remote control fornon-invasively controlling the penile implant. The wireless remotecontrol may comprise at least one external signal transmitter and/orreceiver, further comprising an internal signal receiver and/ortransmitter implantable in the patient for receiving signals transmittedby the external signal transmitter or transmitting signals to theexternal signal receiver.

In one embodiment the wireless remote control transmits at least onewireless control signal for controlling the penile implant.

In one embodiment the wireless control signal comprises a frequency,amplitude, or phase modulated signal or a combination thereof.

In one embodiment the wireless remote control transmits anelectromagnetic carrier wave signal for carrying the control signal.

One embodiment comprises a wireless energy-transmission device fornon-invasively energizing implantable energy consuming components of thepenile implant with wireless energy.

In one embodiment there is provided a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. The signal may be an analogue signal, a digitalsignal, or a combination of an analogue and digital signal

The wireless energy may be different in different embodiments, forexample: an electric field, a magnetic field, or a combined electric andmagnetic field.

The control signal may be different in different embodiments, forexample an electric field, a magnetic field, or a combined electric andmagnetic field.

In another embodiment there is provided an implantable internal energysource for powering implantable energy consuming components of thepenile implant.

In one embodiment there is provided an external energy source fortransferring energy in a wireless mode, wherein the internal energysource is chargeable by the energy transferred in the wireless mode.

In one embodiment there is provided a sensor or measuring device sensingor measuring a functional parameter correlated to the transfer of energyfor charging the internal energy source, and a feedback device forsending feedback information from inside the patient's body to theoutside thereof, the feedback information being related to thefunctional parameter sensed by the sensor or measured by the measuringdevice.

One embodiment further comprises a feedback device for sending feedbackinformation from inside the patient's body to the outside thereof, thefeedback information being related to at least one of a physicalparameter of the patient and a functional parameter related to thepenile implant.

In one embodiment there is provided a sensor and/or a measuring deviceand an implantable internal control unit for controlling the penileimplant in response to information being related to at least one of aphysical parameter of the patient sensed by the sensor or measured bythe measuring device and a functional parameter related to the penileimplant sensed by the sensor or measured by the measuring device. Thephysical parameter may be a pressure or a motility movement.

In one embodiment there is provided an external data communicator and animplantable internal data communicator communicating with the externaldata communicator, wherein the internal communicator feeds data relatedto the penile implant or the patient to the external data communicatorand/or the external data communicator feeds data to the internal datacommunicator.

In one embodiment there is provided a motor or a pump for operating thepenile implant.

In one embodiment there is provided a hydraulic operation device foroperating the penile implant.

In one embodiment there is provided an operation device for operatingthe penile implant, wherein the operation device comprises a servodesigned to decrease the force needed for the operation device tooperate the penile implant instead the operation device acting a longerway, increasing the time for a determined action.

In one embodiment there is provided a operation device for operating thepenile implant, wherein the wireless energy is used in its wirelessstate to directly power the operation device to create kinetic energyfor the operation of the penile implant, as the wireless energy is beingtransmitted by the energy-transmission device.

In one embodiment there is provided an energy-transforming device fortransforming the wireless energy transmitted by the energy-transmissiondevice from a first form into a second form energy.

In one embodiment the energy-transforming device directly powersimplantable energy consuming components of the penile implant with thesecond form energy, as the energy-transforming device transforms thefirst form energy transmitted by the energy-transmission device into thesecond form energy.

In one embodiment the second form energy comprises at least one of adirect current, pulsating direct current and an alternating current.

In one embodiment there is provided an implantable accumulator, whereinthe second form energy is used at least partly to charge theaccumulator.

In one embodiment the energy of the first or second form comprises atleast one of magnetic energy, kinetic energy, sound energy, chemicalenergy, radiant energy, electromagnetic energy, photo energy, nuclearenergy thermal energy, non-magnetic energy, non-kinetic energy,non-chemical energy, non-sonic energy, non-nuclear energy andnon-thermal energy.

In one embodiment there are provided implantable electrical componentsincluding at least one voltage level guard and/or at least one constantcurrent guard.

In one embodiment there is provided a control device for controlling thetransmission of wireless energy from the energy-transmission device, andan implantable internal energy receiver for receiving the transmittedwireless energy, the internal energy receiver being connected toimplantable energy consuming components of the penile implant fordirectly or indirectly supplying received energy thereto, the systemfurther comprising a determination device adapted to determine an energybalance between the energy received by the internal energy receiver andthe energy used for the implantable energy consuming components of thepenile implant, wherein the control device controls the transmission ofwireless energy from the external energy-transmission device, based onthe energy balance determined by the determination device.

In one embodiment the determination device is adapted to detect a changein the energy balance, and the control device controls the transmissionof wireless energy based on the detected energy balance change.

In one embodiment the determination device is adapted to detect adifference between energy received by the internal energy receiver andenergy used for the implantable energy consuming components of thepenile implant, and the control device controls the transmission ofwireless energy based on the detected energy difference.

In one embodiment the energy-transmission device comprises a coil placedexternally to the human body, further comprising an implantable energyreceiver to be placed internally in the human body and an electriccircuit connected to power the external coil with electrical pulses totransmit the wireless energy, the electrical pulses having leading andtrailing edges, the electric circuit adapted to vary first timeintervals between successive leading and trailing edges and/or secondtime intervals between successive trailing and leading edges of theelectrical pulses to vary the power of the transmitted wireless energy,the energy receiver receiving the transmitted wireless energy having avaried power.

In one embodiment the electric circuit is adapted to deliver theelectrical pulses to remain unchanged except varying the first and/orsecond time intervals.

In one embodiment the electric circuit has a time constant and isadapted to vary the first and second time intervals only in the range ofthe first time constant, so that when the lengths of the first and/orsecond time intervals are varied, the transmitted power over the coil isvaried.

In one embodiment there is provided a system comprising an implantableinternal energy receiver for receiving wireless energy, the energyreceiver having an internal first coil and a first electronic circuitconnected to the first coil, and an external energy transmitter fortransmitting wireless energy, the energy transmitter having an externalsecond coil and a second electronic circuit connected to the secondcoil, wherein the external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver, the system further comprising a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off.

In one embodiment there is a an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil, wherein the external second coilof the energy transmitter transmits wireless energy which is received bythe first coil of the energy receiver, the system further comprising afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorsbetween the first and second coils.

In one embodiment the transmitted energy may be regulated depending onthe obtained coupling factor.

In one embodiment there is provided a system wherein the external secondcoil is adapted to be moved in relation to the internal first coil toestablish the optimal placement of the second coil, in which thecoupling factor is maximized.

In one embodiment there is provided a system wherein the external secondcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.

In a yet further aspect there is provided an operation method using apenile implant or system according to the above further comprising thesteps of: a) creating an opening in the skin or penis wall of the malepatient, b) dissecting an one area of the sexually responsive tissue, c)placing the penile implant within said area, adapted to postoperativelystimulate said sexually responsive tissue on patient command.

In one embodiment there is provided an operation method comprising thestep of placing an operation device and a power source within the body.

In one embodiment the operation method comprises placing a penileimplant comprising placing an integrated unit comprising the penileimplant and an operation device in the same integrated unit.

In one embodiment the operation method comprises placing a power sourcecomprising, placing an control unit and a rechargeable battery remotefrom said sexually responsive tissue.

In one embodiment the operation method comprises controlling said penileimplant post-operatively and non-invasively from outside the body.

In one embodiment the operation method comprises the step of creating anopening in the skin or penis wall of the male patient comprising, a)inserting a tube or needle into the patient's body, b) filling the tubeor needle with a gas and thereby expanding a cavity within the malepatients body, c) inserting at least two laparoscopic trocars into saidcavity, d) inserting at least one camera trough at least onelaparoscopic trocar, e) inserting at least one dissecting tool throughat least one laparoscopic trocar.

In one embodiment the penile implant is adapted to be implanted in any,or each, of the corpus cavernosum of the penis of the male patient.

In one embodiment the penile implant is adapted to be implanted in thevicinity of, or in contact with, the glans penis of the penis of themale patient.

According to one embodiment there is provided a system comprising atleast one penile implant. Said penile implant is adapted to bring apenis to an erected state, when said penile implant is implanted in thecorpus cavernosum of the penis and activated or expanded.

Said penile implant is suitably adapted to bring a penis to a flaccidstate, when said penile implant is implanted in the corpus cavernosum ofthe penis and in-activated or collapsed.

According to a further embodiment there is provided a system comprisingtwo penile implants. Said penile implants are adapted to bring a penisto an erected state, when each of said penile implants is implanted in acorpus cavernosum of the penis of a person and activated or expanded.

Said penile implants are suitably adapted to bring a penis to a flaccidstate, when each of said penile implants is implanted in the corpuscavernosum of the penis of a person and in-activated or collapsed.

According to one aspect there is provided a method of implanting thepenile implant in a person or patient.

According to a further aspect there is provided a method of implantingthe system in a person or patient.

In a preferred embodiment, the system comprises at least one switchimplantable in the patient for manually and non-invasively controllingthe penile implant.

In another preferred embodiment, the system comprises a wireless remotecontrol for non-invasively controlling the penile implant.

In a preferred embodiment, the system comprises a hydraulic operationdevice for operating the penile implant.

In one embodiment, the system comprises comprising a motor or a pump foroperating the penile implant.

In one embodiment, the method of implanting the penile implant comprisesthe steps of:

cutting the skin,

dissecting the area of corpus cavernosum,

implanting the implant in corpus cavernosum, and

closing the wound.

In one embodiment, the method implanting the system comprises the stepsof:

cutting the skin,

implanting the energising and control systems subcutaneously in theabdomen or pelvic region of the body, and

closing the wound.

BRIEF DESCRIPTION OF THE DRAWINGS

Before the invention described herein is described in detail, it is tobe understood that it is not limited to the particular component partsof the devices described or process steps of the methods described assuch devices and methods may vary. It is also to be understood that theterminology used herein is for purposes of describing particularembodiments only, and is not intended to be limiting. It must be notedthat, as used in the specification and the appended claims, the singularforms “a,” “an” and “the” also include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “anelement” includes more than one such element, and the like. Theinvention will now be described by way of non limiting embodiments withreference to the accompanying drawings in which:

FIGS. 1a and 2 schematically show different embodiments of a system 700implanted in a person,

FIG. 1b illustrates a system for treating a disease, wherein the systemincludes an penile implant 10 of the invention implanted in a patient,

FIG. 3 is a sectional view showing an implantable device 10 according tothe invention in a collapsed or inactivated state when implanted in thepenis 30 of a patient,

FIG. 4 is a sectional view similar to that of FIG. 3 but showing theimplantable device 10 in an expanded state,

FIGS. 5a, 5b are perspective views showing the expandable section 10 chaving different embodiments of the surface structure 100,

FIG. 6 is a sectional view of a surface structure 100 of the implantabledevice 10,

FIG. 7a is a sectional view similar to that of FIG. 6 but with aslightly different surface structure 100,

FIGS. 7b-d are drawings showing sections of examples of the surfacestructure 100 described herein,

FIG. 8 schematically shows an embodiment of a penile implant 10 having asurface structure 100,

FIGS. 9 and 10 show examples of different cross sections for a penileprosthesis,

FIGS. 11-13 are drawings showing examples of different surfacestructures,

FIGS. 14-19 schematically show a penile implant 10 comprising someembodiments of the pre-formed section 200, 204, 206,

FIGS. 20-26 schematically show a penile implant 10 comprising someembodiments of the bending portion 300, 302,

FIGS. 27-30 schematically show a penile implant 10 which is hollow andat least partly is filled with a foam material 400, 402,

FIGS. 31a-37b schematically show a penile implant 10 having a radiallyexpandable portion 500, 502 and/or a longitudinally expandable portion504. A penile implant 10 comprising a hollow body 12, 12 a, 12 b is alsoschematically shown,

FIGS. 38A and 38B show an implant according to an embodiment.

FIG. 39 shows an implant according to an embodiment, when implanted inthe body of a patient.

FIGS. 40, 41 schematically show an embodiment where the penile implant10 or hollow body 12, 12 a, 12 b comprises a hollow part, alongitudinally expandable segment 564, respectively radially expandablesegments 572 a, 572 b,

FIG. 42 schematically show an embodiment where the penile implant 10 orhollow body 12, 12 a, 12 b is divided in or comprises a first hollow orexpandable portion 584 and a second hollow or expandable portion 586,

FIGS. 43-57 schematically show various embodiments of the system forwirelessly powering the penile implant shown in FIG. 1 b.

FIG. 58 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of energy used for the operation of thepenile implant shown in FIG. 1 b.

FIG. 59 schematically shows an embodiment of the system, in which thepenile implant is operated with wire bound energy.

FIG. 60 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the penile implant shown in FIG. 1 b.

FIG. 61 is a circuit for the arrangement shown in FIG. 60, according toa possible implementation example.

FIGS. 62-68 c show various ways of arranging hydraulic or pneumaticpowering of an penile implant implanted in a patient.

The system 700 may be a system described as system 1000, the system 1000may as well be a system 700.

The operation device 720 may e.g. comprise at least one device selectedfrom the group consisting of the operation device 1007 and 1008.

The control device 722 may e.g. comprise at least one device selectedfrom the group consisting of the devices 1002, 1006, 1004 and 1041.

The conduit 730 may e.g. comprise at least one device selected from thegroup consisting of the conduits 1011 and 1003.

DETAILED DESCRIPTION

Before the device described herein is described in detail, it is to beunderstood that the device is not limited to the particular componentparts of the devices described or process steps of the methods describedas such devices and methods may vary. It is also to be understood thatthe terminology used herein is for purposes of describing particularembodiments only, and is not intended to be limiting. It must be notedthat, as used in the specification and the appended claims, the singularforms “a,” “an” and “the” also include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “anelement” includes more than one such element, and the like.

In FIGS. 1 and 2 penile prosthesis systems 700 implanted in a standingperson having a penis 30 schematically are shown. FIG. 1a schematicallyshows a manually operated system having a manual operating device 702implanted in the scrotum. FIG. 2 schematically shows a powered systemhaving a control device 722 and a powered operating device 720. In bothsystems a penile implant 10 is suitably implanted in each corpuscavernosum of the penis 30.

Some features of an implantable device according to the invention willnow be explained with reference to FIGS. 3 and 4, which show a penileimplant 10 implanted in the penis, generally designated 30, of a patientor person. In this embodiment the implantable device 10 comprises threesections: a first inner end section 10 a and a second outer end section10 b, and an expandable section 10 c provided between the first andsecond end sections 10 a, 10 b. The expandable section 10 c may alsoextend along the complete length of the penile implant 10, or theexpandable section 10 c may extend from the first inner end section 10 aand along the rest of the implant 10.

The implantable device 10 is adapted to be adjustable between acollapsed or inactivated state, in which the expandable section 10 c iscollapsed, see FIG. 3, and an expanded state, in which the expandablesection 10 c is expanded, see FIG. 4.

Surface Structure

One part of the invention is a surface structure 100 comprising elevatedareas 101, 110 alternating with lowered areas 102, 112. The outersurface of the expandable section 10 c may at least partly comprise thissurface structure to provide the mentioned expandability. Theconfigurations and design of the surface structure 100 will be describedin more detail below with reference to FIGS. 5-13.

Examples of the surface structure 100 are shown in perspective in FIGS.5a, 5b , showing the expandable section 10 c partly having a surfacestructure 100.

Referring to FIG. 6, an example of the surface structure 100 comprisingalternating elevated areas 101 and lowered areas 102 will be described.The implantable device 10 may comprise the surface structure 100 havingelevated and lowered areas on at least a part of the outer surface ofthe implantable device 10, which makes it at least partially expandableand collapsible. Adjacent elevated and lowered areas are interconnectedby connecting areas 104. A first distance 108 a between two elevatedareas 101, see FIG. 6, is long enough so as to prevent growth offibrotic tissue directly connecting two adjacent elevated areas 101.That is, it may be possible that fibrotic tissue grows on the surface ofthe elevated and lowered areas 101, 102 and the connecting areas 104.However, thanks to the extension of the first distance 108 a, fibrotictissue is prevented from growing directly from one elevated area 101 toanother adjacent elevated area 101.

With the expression “growing directly from one elevated area 101 toanother elevated area 101” it is e.g. meant that fibrotic tissue growsfrom one elevated area 101 to another while not or only to a smallextent growing on a connecting area 104. As indicated at 104 a in FIG.6, the first distance 108 a may be measured within an interval 104 afrom the level of an elevated area 101. The expression “growing directlyfrom one elevated area 101 to another elevated area 101” also includesthe situation that fibrotic tissue grows on adjacent areas, e.g. twoadjacent connecting areas 104, with such a thickness that the fibrotictissue from each adjacent area meet and bridge the distance or spacebetween two elevated areas 101. In such a situation the space betweentwo elevated areas 101 may be partly or completely filled with fibrotictissue.

It may be suitable that also a second distance 108 b corresponding tothe extension of a lowered area 102 has an extension great enough so asto prevent fibrotic tissue from growing directly from one connectingarea 104 to another connecting area 104. With the expression “growingdirectly from one connecting area 104 to another connecting area 104” itis meant that fibrotic tissue grows from one connecting area 104 toanother while not or only to a small extent growing on a lowered area102.

In FIG. 6 a surface structure comprising elevated and lowered areas hasbeen shown, but apart from elevated and lowered areas also many othergeometrical structures may be used where it is possible to fulfill theabove mentioned prevention of growth of fibrotic tissue. In particularthe above mentioned prevention of growth of fibrotic tissue betweenelevated areas and between connecting areas.

Some examples of such other geometrical structures are shown in FIGS. 57and 11-13. In a surface structure comprising ridges and grooves, theridges and grooves may also have different sections, some examples areshown in FIGS. 7a -7 d.

Referring mainly to FIGS. 6 and 7 a some expressions and aspects willnow be explained. In this application the concept of a first distance108 a, 118 a between adjacent elevated areas 101, 110 is used. With sucha first distance 108 a, 118 a it is meant a distance that is measuredsubstantially from the edge 106, 114 of one elevated area 101, 110 tothe edge 106, 114 of an adjacent elevated area 101, 110. Measuredsubstantially from the edge means that the measurement may be donewithin a first interval 104 a from the level of an elevated area 101,110, the first interval 104 a extending from the level of an elevatedarea 101, 110 towards the level of an adjacent lowered area 102, 112.

In this application also the concept of a second distance 108 b, 118 bbetween adjacent connecting areas 104, 116 is used. With such a seconddistance 108 b, 118 b it is meant a distance that is measuredsubstantially from the connection point between a connecting area 104,116 and a lowered area 102, 112 to another connection point involving anadjacent connecting area 104, 116. Measured substantially from theconnection point means that the measurement may be done within a secondinterval 104 b from the level of a lowered area 102, 112, the secondinterval 104 b extending from the level of a lowered area 102, 212towards the level of an adjacent elevated area 101, 110.

With elevated and lowered areas it is meant areas that lie in differentplanes 103, 105, 120, 122 where the planes are separated by a distance107, 124, 128. The planes may be parallel or substantially parallel butmay also be non-parallel. If the planes are parallel, defining adistance between them is trivial. If the planes are non-parallel (as inFIG. 7a ) a distance between the planes may be defined by a normal 124,128 to one of the planes 120, 122 where the normal extend to a point onan area in another plane 122, 126 and the distance between the planes isequal to the extension of the normal 124, 128. As seen in FIG. 7a thenormal 124, 128 extends from a plane 120, 122 to a point which isapproximately equally distant from the edges of an area. There are twopossible ways to define the normal or distance between the planes.Taking normal 128 as example, one may define the normal as in 128 a orin 128 b. It may be suitable to define the distance between two planesas the extension of the longest normal, the distance between the planes120 and 122 would then be equal to the extension of normal 128 a. Thisdefinition will be used hereafter.

The elevated and lowered areas may have different shapes, they may beplane or substantially plane but they may also have some kind of curvedshape.

The elevated areas 101, 110 connect to adjacent lowered areas 102, 112by means of connecting areas 104, 116. The connection betweenelevated/lowered areas and connecting areas 104, 116 may comprise aradius of different sizes, bigger or smaller radii. When the radius isvery small there will substantially be an edge 106, 114 connecting theareas.

The expression “expandable section” implies that said section also iscollapsible.

Suitably the implantable device 10 at least partly comprises materialswhich have a high degree of biocompatibility, such materials may becalled physiologically inert, biologically inert or biocompatible.

As said before, an suitable application for such an implantable device10 is a penile prosthesis for curing erectile impotence. The implantabledevice 10 may at least partly be expandable and/or collapsible and theformation of fibrotic tissue on such an implantable device 10 couldimpede the function or even render the function of the implantabledevice 10 impossible. But, an implantable device 10 comprising a surfacestructure 100 as described herein would not be impeded, or at least onlyimpeded to a small degree, in its function.

A penile implant 10 including a surface structure 100 is suitablyadapted to be adjustable between a first state and a second state,suitably a first collapsed state and a second expanded state. The penileimplant may be activated and/or expanded to different degrees, e.g.fully activated or to some degree partly activated. The first state maye.g. be an in-activated state and the second state may e.g. be anactivated state with any degree of activation. The first and secondstates may also be activated states with different degrees ofactivation. The mentioned examples for the first and second state areexamples, the first and second state may be any two states which thepenile implant can assume. Of course it is possible that the penileimplant can assume any number of states.

The meaning of partly activated and fully activated may be illustratedwith a penile implant which is adjustable in size, as discussed in thesection “Summary”. The maximum size of the penile implant is reachedwhen the penile implant is fully activated and by partly activating thepenile implant to different degrees any size between maximum and minimummay be achieved. The activation may for example be effected bytransporting a transportable medium to a hollow body within the implant,but also other means of activation is possible, e.g. mechanical.

Referring in particular to FIGS. 6 and 7 a, in the surface structure 100there may suitably be a specified first distance 108 a, 118 a betweenadjacent elevated areas 101, 110. The distance between adjacent elevatedareas 101, 110 is chosen so that fibrotic tissue cannot bridge the firstdistance 108 a, 118 a between adjacent elevated areas 101, 110. Hence,the first distance 108 a, 118 a between adjacent elevated areas 101, 110is suitably big enough to prevent the formation of fibrotic tissue thatbridges adjacent elevated areas 101, 110.

As mentioned before, there may suitably be a specified second distance108 b, 118 b between adjacent connecting areas 104, 116. The seconddistance 108 b, 118 b between adjacent connecting areas 104, 116 ischosen so that fibrotic tissue can not bridge the second distance 108 b,118 b between adjacent connecting areas 104, 116. Hence, the seconddistance 108 b, 118 b between adjacent connecting areas 104, 116 issuitably big enough to prevent the formation of fibrotic tissue thatbridges adjacent connecting areas 104, 116. Some suitable intervals forthe first and second distances are mentioned in the section “Summary”.

It may also be suitable that a third distance 107, 124, 128 a betweenthe different planes 103, 105, 120, 122, 126 of the elevated and loweredareas is bigger than a certain threshold to facilitate the collapsibleand/or expandable functionality of the implant. If the third distance107, 124, 128 a is too small the collapsible and/or expandablefunctionality of the penile implant may be limited. A suitable intervalfor the third distance 107, 124, 128 a is around 0.5 to 10 mm, moresuitable around 2-8 mm and most suitable around 3-7 mm. Also regardingthe aspect that the fibrotic tissue should not impede thecollapsible/expandable functionality of the implantable device it issuitable that the distance 107, 124, 128 a is not too small, butsuitably in the interval/s as mentioned previously.

The surface structure 100 may include objects or elements of differentgeometrical shapes, for example ridges of different shapes, embossmentsof different shapes and other objects which enable a surface structureas described herein. The area of the elevated areas 101, 110 may be verysmall while still resulting in a surface structure that has the desiredfunctionality. The area of the elevated areas 101, 110 may even bealmost zero, as exemplified in FIG. 7d . Whereas FIGS. 6 and 7 a-7 dshow cross sections of examples of surface structures 100, FIGS. 5a, 5band 11-13 show examples of different surface structures 100 inperspective. The objects or elements in the surface structure 100 may beplaced in rows, ordered in some other way, or may be more or lessrandomly distributed over the surface of the implant. Different types ofobjects may also be used together in the surface structure 100, e.g. acombination of pyramid shaped and cone shaped objects together withridges of some shape.

In FIGS. 8-10 an embodiment of a penile prosthesis or penile implant 10is shown where a surface structure 100 is used, the penile implant 10 isnot shown in full. FIG. 8 shows a longitudinal section of the penileimplant 10 where 140 denotes the surface structure on the upper side ofthe penile implant 10 and 142 denotes the surface structure on the underside of the penile implant 10. As shown in FIG. 8 the surface structure142 on the under side may have a greater extension than the surfacestructure 140 on the upper side of the penile prosthesis. This gives thepenile implant 10 an up-bent position when the penile implant 10 isexpanded. This may be suitable since a normally functioning penis has anup-bent position when erected and it is suitable if a penile prosthesisresembles a normally functioning penis. This aspect is more closelydiscussed in the parts of the application covering the aspect bendingportion 300, 302, 302. The surface structures 140 and 142 are oneexample of a bending portion 300, 302, 302. FIG. 9 shows a cross sectionof the penile implant 10 where the penile implant 10 includes a waistportion 144, where the waist portion comprises waist surface structures146 and 148. The waist portion with the waist surface structures 146 and148 make the penile implant 10 expandable also in the radial direction.The penile implant 10 may also have a cross section as shown in FIG. 10comprising a waist portion 144 having four waist surface structures 150,152, 154, 156 further facilitating the ability of the penile implant 10to be expandable also in the radial direction. The cross sections inFIGS. 9 and 10 are taken along the line A1-A2 in FIG. 8. Radial andlongitudinal expandability and means therefore is described more closelyin the parts of the application covering the features radiallyexpandable section 500, 502 and longitudinally expandable section 504.

Pre-Formed Section

In FIGS. 14-19 some embodiments of the pre-formed section are shown.Each embodiment is shown both when the penile implant 10 is in itscollapsed or inactivated state, FIGS. 14, 16 and 18, and when the penileimplant 10 is in an activated and/or expanded state, FIGS. 15, 17 and19. In FIGS. 14 and 15 the pre-formed section 200 comprises a bellowshaped first inner pre-formed part 201 and a bellow shaped second outerpre-formed part 202. This embodiment is suitable e.g. since it ispossible to give the different parts 201, 202 different radii so thatthe penis 30 will have a natural appearance when the penile implant 10is implanted and collapsed or inactivated. Also from the aspect ofreducing or avoiding bending creases in the penile implant 10 it may bean advantage to design different parts of the pre-formed sectiondifferently. In case the pre-formed section comprises a bellow shapedpart e.g. the depth of the bellow structure and the extension of theridges and grooves in a direction transversal to the longitudinaldirection of the penile implant may be altered. As shown in FIG. 1a 5the pre-formed section 200 is designed so that the penis 30 adopts asubstantially straight shape when the penile implant 10 is implanted andactivated and/or expanded.

In FIGS. 16 and 17 the pre-formed section 204 comprises an even surfaceand is pre-formed so that bending creases are avoided or reduced whenthe penile implant 10 is implanted and the penis is in a relaxedposition, and so as to give the penis 30 a natural appearance when thepenile implant 10 is implanted and collapsed or inactivated. As shown inFIG. 1a 7 the pre-formed section 204 is also designed so that the penis30 adopts a substantially straight shape when the penile implant 10 isimplanted and activated and/or expanded. This can be achieved e.g. byforming the underside of the pre-formed section 204 of a material havinggreater elasticity than the material of the upper side of the pre-formedsection 204, so that the underside of the pre-formed section 204 shows agreater longitudinal expansion than the upper side when the penileimplant 10 is activated and/or expanded. Activation or expansion of thepenile implant 10 may e.g. comprise filling the same with a pressurizedtransportable medium, e.g. a fluid.

In FIGS. 18 and 19 the pre-formed section 206 comprises a fold or pleatdesigned so that bending creases are avoided or reduced when the penileimplant 10 is implanted and the penis is in a relaxed position, and soas to give the penis 30 a natural appearance when the penile implant 10is implanted and collapsed or inactivated. As shown in FIG. 19 thepre-formed section 206 is also designed so that the penis 30 adopts asubstantially straight shape when the penile implant 10 is implanted andactivated and/or expanded.

As seen in FIG. 20 the penis 30 can be said to have a pendulous penisportion 30 b, extending outside the body and being the part to the leftof the line 30 a, and a root penis portion 30 c extending inside thebody and being the part to the right of the line 30 a. The penileimplant 10 has a distal portion 10 d located in the pendulous penisportion 30 b and a proximal portion 10 e located in the root penisportion 30 c.

Bending Portion

In FIGS. 20-26 the aspect bending portion is illustrated. In FIG. 20 onesuitable location on the penile implant 10 of a bending portion 300, 302is illustrated. The penile implant 10 is implanted in the corpuscavernosum of a penis 30. The penile implant 10 is connected to apowered operating device 702 and a control device 704 and is part of apenile prosthesis system. Of course a penile implant 10 according to anyembodiment and comprising any aspect or feature described herein, orcombination thereof, can be connected to a powered operating device 702and a control device 704 and be part of a penile prosthesis system. Thebending portion 300, 302 shown in FIG. 23a is bellow shaped and thedepth of the bellows structure 304 is greater on the underside of thebending portion 300, 302 than on the upper side. In this way a penileimplant 10 comprising the bending portion 300, 302 will bend upwardlywhen the penile implant 10 is activated and/or expanded since theunderside of the bending portion 300, 302 will show a greaterlongitudinal expansion than the upper side. In FIG. 23b a bendingportion 300, 302 having a pliable top wall 308 a and a pliable bottomwall 308 b in illustrated. The bottom wall 308 b is designed tolongitudinally distend more than the top wall 308 a, when the penileimplant 10 is activated, e.g. expanded. In FIGS. 21 and 22 a penileimplant 10 comprising a bending portion 300, 302 is shown in a collapsedor inactivated respectively an activated and/or expanded state. In FIGS.24-26 a bending portion 302 is shown having an alternative embodimentwith a bellows structure 306 where the underside of the bending portion302 has a greater longitudinal extension than the upper side. Thefunction is the same as is the embodiment shown in FIGS. 21-23. Theembodiments respectively illustrated in FIGS. 21-23 and 24-26 may alsobe combined.

As shown in e.g. FIGS. 22 and 25, said penile implant comprises abending portion 300, 302 placed or located between the proximal 10 e anddistal portion 10 d, or in the vicinity of the position where theproximal and distal portion 10 d meet, said bending portion 300, 302being adapted to enable said penile implant 10, when said penile implant10 is implanted and activated, to bring at least the pendulous orprotruding portion 30 b of the penis 30 to a position in which the penis30 has an acute angle with the vertical plane when said person isstanding, that is, a position in which at least the pendulous orprotruding portion 30 b of the penis is upwardly bent when said personis standing, and in which position the distal portion 10 d is moreupwardly oriented than the proximal portion 10 e.

Pre-Filled

In FIGS. 27-30 a penile implant 10 is shown which is hollow or comprisesa hollow body 12, 12 a, 12 b and where the penile implant 10 or hollowbody 12, 12 a, 12 b at least partly, but preferably completely, isfilled with a foam material 400, 402. The hollow body is illustrated inFIGS. 31c, 31d . In FIG. 28 the foam material 400 is illustrated by thecross hatched area. As shown in FIG. 29, a foam material 402 comprisingclosed spaces or compartments 404 which contain a gas, e.g. air may alsobe used. Such a foam material 402 is very light which is an advantage asdiscussed is the summary. In general, suitably the foam material 400,402 is of the closed cellular type. In FIGS. 28 and 29 the penileimplant 10 is in an activated state. In FIG. 30 a penile implant 10 asin FIGS. 28 and 29 is shown in a relaxed state. The penile implant 10 inFIGS. 28-30 comprises a bending portion 300, 302 but the penile implant10 may of course comprise a foam material 400, 402 without having abending portion 300, 302.

The penile implant 10, is adapted to be implanted in the corpuscavernosum of a penis (30) of a person. Said penile implant 10 ispreferably at least partly hollow and/or at least partly comprises ahollow body 12, 12 a, 12 b, said penile implant preferably comprising afoam material 400, 402 transparent for fluid, said foam material 400,402 filling the hollow part of said penile implant 10 and/or said hollowbody 12, 12 a, 12 b in a first inactivated state where the penis is in aflaccid state, and wherein said foam material 400, 402 has a lowerdensity than water, and wherein said foam material being transparent forfluid and filling the hollow part of said penile implant 10 and/or saidhollow body 12, 12 a, 12 b is adapted to be filled with a fluid in asecond activated state, which fluid in said second activated statecreates an penile erection, to together substantially fill the volume ofthe hollow part of said penile implant 10 and/or said hollow body 12, 12a, 12 b.

The outer surface of said foam material being transparent for fluid maybe integrated in the surface delimiting the hollow part of said penileimplant 10 and/or said hollow body 12, 12 a, 12 b.

According to one embodiment, there is provided a penile implant whereinsaid penile implant is adapted to be implanted in the corpus cavernosumof a penis of a person, and

wherein said penile implant at least partly is hollow and/or at leastpartly comprises a hollow body, said penile implant comprising closedspaces, suitably bubbles, which contain, or are filled with, a solidmaterial, a gas or a fluid, e.g. air or foam material, said closedspaces being arranged at the surface delimiting the hollow part of saidpenile implant and/or said hollow body, and

wherein the hollow part of said penile implant and/or said hollow bodyis adapted to be filled with a fluid in a second activated state, whichfluid in said second activated state creates an penile erection.

According to one embodiment, there is provided a penile implant whereinsaid fluid is adapted to be received into and pressurize said penileimplant and/or said hollow body, to bring said penile implant into saidsecond activated state, or to be withdrawn from said penile implantand/or said hollow body, to bring said penile implant into said firstin-activated flaccid state.

According to one embodiment, there is provided a penile implant whereinthe hollow space arranged for receiving the fluid in said penile implantis arranged longitudinally along the penile implant.

According to one embodiment, there is provided a penile implant whereinsaid closed spaces being arranged at the surface delimiting the hollowpart of said penile implant and/or said hollow body are arranged in abody integrated with the outer part of said penile implant where saidbody and said outer part of said penile implant are made of differentmaterials.

In any of the embodiments where foam material 400, 402 fills the hollowpart of said penile implant 10 and/or said hollow body 12, 12 a, 12 b ina first inactivated state where the penis is in a flaccid state, it ispossible that said penile implant and said foam material, are: arrangedintegrated, attached to each other by using e.g. adhesive or glue,molded in one piece, made of same material, or made of differentmaterial.

In any of the embodiments where said penile implant comprises closedspaces, suitably bubbles, which contain, or are filled with, a solidmaterial, a gas or a fluid, e.g. air or foam material, said closedspaces being arranged at the surface delimiting the hollow part of saidpenile implant and/or said hollow body, it is possible that said penileimplant and said body comprising the closed spaces, are: arrangedintegrated, attached to each other by using e.g. adhesive or glue,molded in one piece, made of same material, or made of differentmaterial.

Radial and Longitudinal Expansion

In FIGS. 31-37 and 40-42 a penile implant 10 having a radiallyexpandable portion 500, 502 and/or a longitudinally expandable portion504 is illustrated. In FIG. 31 a two penile implants 10 coupled to amanual operation device 702 are shown. Suitably one penile implant 10 isimplanted in each corpus cavernosum. Generally and in any embodiment, ifthe penile implant 10 is activated by a pressurized fluid suitably thepenile implant 10 is at least partly hollow or at least partly comprisesa hollow body 12, 12 a, 12 b, where the penile implant 10 or the hollowbody 12, 12 a, 12 b is adapted to be filled and pressurized with afluid. In FIGS. 31c, 31d the hollow body 12, 12 a, 12 b is shown in twoembodiments, one where the penile implant 10 comprises one hollow body12 and another where the penile implant 10 comprises two hollow bodies12 a, 12 b. The hollow bodies 12, 12 a, 12 b or the penile implant 10are/is suitably connected to an operation device 720, 702 by a conduit730 adapted to convey fluid. In FIG. 32 a penile implant 10 implanted inthe corpus cavernosum of a penis and connected by a conduit 730 to anoperation device 702 implanted in the scrotum 34 is shown in its relaxedstate. The radially expandable portion 500, 502 may e.g. be waist formedand comprise two indentations 512, 526 as shown in FIGS. 33a, 33e orcomprise one indentation 530 as in FIG. 33b and may extend alongsubstantially the complete length of the penile implant 10. In FIG. 33ca penile implant 10 is shown where the radially expandable portion 500,502 extends along a part of the length of the penile implant 10. Theradially expandable portion 500, 502 may e.g. extend from a point atapproximately 2 or 3 cm distance from the proximal end 534 to a point atapproximately 1 cm distance from the distal end 536 of the penileimplant 10. FIG. 34 schematically shows the penile implant 10 in FIG. 32in an expanded state. FIG. 33a shows a cross section of a penis 30 wherea penile implant 10 is implanted in each corpus cavernosum, and has aradially expandable portion 500 comprising two indentations 512, 526.The penile implants 10 are in their collapsed state in FIG. 33a .Reference number 32 denotes the envelope of fibrous tissue thatsurrounds each corpus cavernosum. FIG. 33d shows the penile implants 10in FIGS. 33a, 33b in an expanded state. FIG. 33b shows a cross sectionof a penis 30 where a penile implant 10 having a radially expandableportion 502 is implanted in each corpus cavernosum and is in itscollapsed state. The radially expandable portion 502 comprises oneindentation 530 which faces the urethra 34. FIG. 33e shows the distance524 between the substantially opposing sides 512 a and 512 b of theindentation 512 and the depth 518 of the indentation or concaveness 512.As for the surface structure 100, the distance 524 may be measuredwithin an interval 520 from the top or opening 514 of the indentation512 and/or within an interval 522 from the bottom 516 of the indentation512. This is analogous with the definition of the distances 108 a, 108b, 118 a, 118 b. The distance 524 may e.g. be around 3 mm and it issuitable that this means that the distance 524 should be around 3 mm atsome level within the interval 522 and at some level within the interval520. What has been stated about distance and depth for the indentation512 is also valid for the indentations 526 and 530.

FIG. 35 shows a penile implant 10 having a radially expandable portion500, 502 and a longitudinally expandable portion 504. The longitudinallyexpandable portion 504 is located in the area where the proximal portion10 e and distal portion 10 d of the penile implant 10 meet, which is onesuitable location. In FIGS. 36a, 36b and 37a, 37b the penile implant 10in FIG. 35 is shown in a collapsed respectively in an expanded state.

In FIGS. 40, 41 an embodiment is shown where the penile implant 10comprises a hollow part adapted to be filled and pressurized with afluid, the hollow part may be realized in that the penile implant 10itself is hollow or it may comprise a hollow body 12, 12 a, 12 b. Thehollow part 10, 12, 12 a, 12 b is divided in compartments 560, 562separated by dividing wall(s) 566 having a valve 568 which at a firstside A opens for fluid flow from the first side A when the fluidpressure at the first side A exceeds a certain pressure value butotherwise is closed for fluid flow from the first side A. At the secondside B of the valve 568 the valve opens for fluid flow from the secondside B already when the fluid pressure at the second side is very low,suitably at substantially zero pressure, this to enable emptyingcompartment 562 and collapsing invagination 564. The compartment 562 onthe second side B of the wall 566 has at least one invagination 564.Line 564 i shows the invagination 564 in its invaginated or collapsedform and line 564 ii in its expanded form. In this way a firstcompartment 560 on the first side A of a dividing wall 566 can be filledand pressurized with fluid to make the implant 10 hard and stiff at afirst size, and by further increasing the pressure of the fluid a secondcompartment 562 on the second side B of the dividing wall 566 can befilled and pressurized with fluid to make the implant 10 hard and stiffat a second, greater size when the invagination 564 bulge due to thefluid pressure. Suitably the first compartment 560 is adapted to alwaysbe filled and pressurized with fluid when the implant 10 is activated.Suitably the penile implant 10 is activated in that the operation device702, 722 is controlled to fill and pressurize the first compartment 560with fluid to a first pressure level, where the patient or user of thesystem can select to increase the pressure to fill and pressurize alsothe second compartment 562 to achieve a larger erected penis. The partof the penile implant 10 or hollow body 12, 12 a, 12 b that comprisesthe first compartment 560 may as well comprise a radially and/orlongitudinally expandable portion 500, 502, 504 or any other feature oraspect described herein. Wall part 570 is optional. FIG. 40 shows alongitudinally expandable portion 574 having a compartment 562 forlongitudinal expansion and FIG. 41 two compartments 562 a, 562 b forradial expansion having two radially expandable segments 572 a, 572 b.The invagination 564 in FIG. 41 may e.g. be an indentation 512, 526, or530. Instead of two compartments 562 a, 562 b for radial expansion theremay be provided one compartment 562 for radial expansion having oneradially expandable segment 572, suitable e.g. if the penile implant 10or hollow body 12, 12 a, 12 b has a cross section presenting anindentation 530 as shown in FIG. 33 b.

The radially expandable segment(s) 572, 572 a, 572 b may be adapted toassume any desired radial dimension when the compartment(s) 562, 562 a,562 b are filled with and pressurized by fluid. One example of a radialdimension of the radially expandable segment(s) 572, 572 a, 572 b in theexpanded state is illustrated by the continuous lines indicated by 572a, 572 b. Another example is illustrated by the broken lines indicatedby 576 a, 576 b and illustrating another radial dimension of theradially expandable segment(s) 572, 572 a, 572 b. The radiallyexpandable segment(s) 572, 572 a, 572 b may extend along a part of oralong the whole distal portion of the penile implant 10. If desired, theradially expandable segment(s) 572, 572 a, 572 b may also extend alongthe proximal portion of the penile implant. The compartment 562 andinvagination 564 in FIG. 40 may have any desired size or length toachieve any desired prolongation of the penile implant 10 when thecompartment 562 is filled with and pressurized by fluid. Hence, toachieve any desired prolongation of the penis 30 when the penile implant10 is implanted in a corpus cavernosum of the penis 30 and thecompartment 562 is filled with and pressurized by fluid.Correspondingly, the size of the radially expandable segment(s) 572, 572a, 572 b may be adapted to achieve any desired radial expansion of thepenis 30.

In FIG. 42 an embodiment is shown where the penile implant 10 or hollowbody 12, 12 a, 12 b is divided in a first hollow portion 584 and asecond hollow portion 586 connected by a flexible conduit, e.g. oneflexible conduit 580 a or two flexible conduits 580 a, 580 b, and aflexible portion 582. Each hollow portion 584, 586 has an invagination564 a, 564 b where the invaginations 564 a, 564 b are facing each otherand are adapted to bulge and mutually exert a force on each other whensubjected to fluid pressure, so as to prolong the penile implant 10and/or hollow body 12, 12 a, 12 b when the first and second hollowportions 584, 586 are filled and pressurized with a fluid, wherein theinvaginations 564 a, 564 b are adapted to resume their invaginated orcollapsed form when the fluid pressure is removed so that the penileimplant 10 and/or hollow body 12, 12 a, 12 b resumes its not prolongedlength. When the penile implant 10 is activated and the hollow portions584, 586 are filled and pressurized with the fluid pumped by theoperation device 702, 722 the flexible conduits 580 a, 580 b, and theflexible portion 582 naturally also prolong. The embodiments in FIGS.40-42 may naturally be combined in any way.

Vibrating Unit

In FIGS. 38-39 a vibration device 600 and a penile implant 10 comprisingsuch a device is shown. FIG. 38a shows one exemplary location of avibration device 600 in each penile implant 10 of a penile prosthesissystem 700. FIG. 38b schematically shows one exemplary embodiment of thevibration device 600 comprising an outer shell 602, a motor 604, a firstmotor axis 606, an eccentric element 608 eccentrically mounted to thefirst motor axis 606, a second axis 610 which suitably is supported by abearing mounted to the outer shell 602. FIG. 32 shows a penile implant10 having a vibration device 600, implanted in the corpus cavernosum ofa penis and connected by a fluid conduit 730 to an operation device 720and to a control device 722 in its relaxed state. In FIG. 39 letters a,b, c and d indicates alternative locations for the vibration device 600.The vibration device 600 may of course be implanted directly in thepenis or in the region of the penis and need not be located in a penileimplant 10. FIG. 38c schematically shows one exemplary embodiment of thevibration device 600 comprising an electromagnetic device 620.

Generally, in any embodiment of the penile implant 10 or vibrationdevice 600, a sensor 1070, 1025, 1043 may measure at least onephysiological or functional parameter. The location of the sensor 1070,1025 is adapted to the circumstances, e.g. which parameter that shouldbe measured. The sensor 1070, 1025 may e.g. be connected to the controldevice 722 via a communication line 1072 that also may supply power tothe sensor 1070, 1025.

The control device 722 or operation device 720 may comprise at least oneitem selected from the group consisting of; an energy-transformingdevice 1002, a control unit 1041, a battery 1042, a sensor 1043, a motor1044, a pump 1045, a reservoir 1046 or an injection port 1047. The itemsbeing selected depending on the circumstances, e.g. if the apparatus iselectrically, hydraulically, pneumatically or mechanically operated.

If a non-rechargeable battery is used the energy-transforming device1002 may be omitted but the items 1041 to 1047 may be used as suitable,and be connected to the penile implant 10, vibration device 600 andsensor 1070, 1025, 1043 as suitable. If e.g. the penile implant 10 ishydraulically operated it may e.g. be suitable to use a control unit1041, a pump 1045 and/or a reservoir 1046, the connection to the penileimplant 10 suitably being a hydraulic conduit.

In general, any item, or combinations of items, described and suitedtherefore, may be connected to the penile implant 10 via the powersupply line 1003, 730. The actual item, or combinations of items, beingchosen depending on the circumstances, e.g. if the penile implant 10 iselectrically, hydraulically, pneumatically or mechanically operated.This is valid for any embodiment of the penile implant 10 or vibrationdevice 600, described in any figure.

If e.g. the penile implant 10 is mechanically operated it may beconnected to a motor 1044 via the power supply line 1003, 730 which inthis case may be a wire or bowden cable. A control unit 1041 may beconnected to the motor 1044.

If e.g. the penile implant 10 is electrically operated it may besuitable to connect it to a source of electrical energy 1002 or 1042 viathe power supply line 1003, 730 which in this case may be an electricalconduit. A control unit 1041 or control device 722 may be connected tothe source of electrical energy 1002 or 1042.

System, e.g. a Penile Prosthesis System

FIG. 1b schematically illustrates a system for treating a diseasecomprising an penile implant 10 of the present invention placed in apatient. An implanted energy-transforming device 1002 is adapted tosupply energy consuming components of the penile implant with energy viaa power supply line 1003. An external energy-transmission device 1004for non-invasively energizing the penile implant 10 transmits energy byat least one wireless energy signal. The implanted energy-transformingdevice 1002 transforms energy from the wireless energy signal intoelectric energy which is supplied via the power supply line 1003.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 1004 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 1002 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 1004 into energy of a second form, whichtypically is different from the energy of the first form. The implantedpenile implant 10 is operable in response to the energy of the secondform. The energy-transforming device 1002 may directly power the penileimplant with the second form energy, as the energy-transforming device1002 transforms the first form energy transmitted by theenergy-transmission device 1004 into the second form energy. The systemmay further include an implantable accumulator, wherein the second formenergy is used at least partly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 1004 may be used to directly power the penileimplant, as the wireless energy is being transmitted by theenergy-transmission device 1004. Where the system comprises an operationdevice for operating the penile implant, as will be described below, thewireless energy transmitted by the energy-transmission device 1004 maybe used to directly power the operation device to create kinetic energyfor the operation of the penile implant.

The wireless energy of the first form may comprise sound waves and theenergy-transforming device 1002 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current. Normally, the penile implant compriseselectric components that are energized with electrical energy. Otherimplantable electric components of the system may be at least onevoltage level guard or at least one constant current guard connectedwith the electric components of the penile implant.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatient's body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating thepenile implant. Alternatively, the energy-transmission device iscontrolled from outside the patient's body to release non-magneticwireless energy, and the released non-magnetic wireless energy is usedfor operating the penile implant.

The external energy-transmission device 1004 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the penileimplant. The control signal is received by an implanted signal receiverwhich may be incorporated in the implanted energy-transforming device1002 or be separate there from.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

FIG. 43 illustrates the system of FIG. 1b in the form of a moregeneralized block diagram showing the penile implant 10, theenergy-transforming device 1002 powering the penile implant 10 via powersupply line 1003, and the external energy-transmission device 1004, Thepatient's skin 1005, generally shown by a vertical line, separates theinterior of the patient to the right of the line from the exterior tothe left of the line.

FIG. 42 shows an embodiment of the invention identical to that of FIG.43, except that a reversing device in the form of an electric switch1006 operable for example by polarized energy also is implanted in thepatient for reversing the penile implant 10. When the switch is operatedby polarized energy the wireless remote control of the externalenergy-transmission device 1004 transmits a wireless signal that carriespolarized energy and the implanted energy-transforming device 1002transforms the wireless polarized energy into a polarized current foroperating the electric switch 1006. When the polarity of the current isshifted by the implanted energy-transforming device 1002 the electricswitch 1006 reverses the function performed by the penile implant 10.FIG. 45 shows an embodiment of the invention identical to that of FIG.43, except that an operation device 1007 implanted in the patient foroperating the penile implant 10 is provided between the implantedenergy-transforming device 1002 and the penile implant 10. Thisoperation device can be in the form of a motor 1007, such as an electricservomotor. The motor 1007 is powered with energy from the implantedenergy-transforming device 1002, as the remote control of the externalenergy-transmission device 1004 transmits a wireless signal to thereceiver of the implanted energy-transforming device 1002.

FIG. 46 shows an embodiment of the invention identical to that of FIG.43, except that it also comprises an operation device is in the form ofan assembly 1008 including a motor/pump unit 1009 and a fluid reservoir1010 is implanted in the patient. In this case the penile implant 10 ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 1009 from the fluid reservoir 1010 through a conduit 1011 to thepenile implant 10 to operate the penile implant, and hydraulic fluid ispumped by the motor/pump unit 1009 back from the penile implant 10 tothe fluid reservoir 1010 to return the penile implant to a startingposition. The implanted energy-transforming device 1002 transformswireless energy into a current, for example a polarized current, forpowering the motor/pump unit 1009 via an electric power supply line1012.

Instead of a hydraulically operated penile implant 10, it is alsoenvisaged that the operation device comprises a pneumatic operationdevice. In this case, the hydraulic fluid can be pressurized air to beused for regulation and the fluid reservoir is replaced by an airchamber.

In all of these embodiments the energy-transforming device 1002 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.

As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patient's hand most likely indirect, for example a press buttonplaced under the skin. FIG. 47 shows an embodiment of the inventioncomprising the external energy-transmission device 1004 with itswireless remote control, the penile implant 10, in this casehydraulically operated, and the implanted energy-transforming device1002, and further comprising a hydraulic fluid reservoir 1013, amotor/pump unit 1009 and an reversing device in the form of a hydraulicvalve shifting device 1014, all implanted in the patient. Of course thehydraulic operation could easily be performed by just changing thepumping direction and the hydraulic valve may therefore be omitted. Theremote control may be a device separated from the externalenergy-transmission device or included in the same. The motor of themotor/pump unit 1009 is an electric motor. In response to a controlsignal from the wireless remote control of the externalenergy-transmission device 1004, the implanted energy-transformingdevice 1002 powers the motor/pump unit 1009 with energy from the energycarried by the control signal, whereby the motor/pump unit 1009distributes hydraulic fluid between the hydraulic fluid reservoir 1013and the penile implant 10. The remote control of the externalenergy-transmission device 1004 controls the hydraulic valve shiftingdevice 1014 to shift the hydraulic fluid flow direction between onedirection in which the fluid is pumped by the motor/pump unit 1009 fromthe hydraulic fluid reservoir 1013 to the penile implant 10 to operatethe penile implant, and another opposite direction in which the fluid ispumped by the motor/pump unit 1009 back from the penile implant 10 tothe hydraulic fluid reservoir 1013 to return the penile implant to astarting position.

FIG. 48 shows an embodiment of the invention comprising the externalenergy-transmission device 1004 with its wireless remote control, thepenile implant 10, the implanted energy-transforming device 1002, animplanted internal control unit 1015 controlled by the wireless remotecontrol of the external energy-transmission device 1004, an implantedaccumulator 1016 and an implanted capacitor 1017. The internal controlunit 1015 arranges storage of electric energy received from theimplanted energy-transforming device 1002 in the accumulator 1016, whichsupplies energy to the penile implant 10. In response to a controlsignal from the wireless remote control of the externalenergy-transmission device 1004, the internal control unit 1015 eitherreleases electric energy from the accumulator 1016 and transfers thereleased energy via power lines 1018 and 1019, or directly transferselectric energy from the implanted energy-transforming device 1002 via apower line 1020, the capacitor 1017, which stabilizes the electriccurrent, a power line 1021 and the power line 1019, for the operation ofthe penile implant 10.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the penile implant 10 according to apre-programmed time-schedule or to input from any sensor sensing anypossible physical parameter of the patient or any functional parameterof the system.

In accordance with an alternative, the capacitor 1017 in the embodimentof FIG. 48 10 may be omitted. In accordance with another alternative,the accumulator 1016 in this embodiment may be omitted.

FIG. 49 shows an embodiment of the invention identical to that of FIG.43, except that a battery 1022 for supplying energy for the operation ofthe penile implant 10 and an electric switch 1023 for switching theoperation of the penile implant 10 also are implanted in the patient.The electric switch 1023 may be controlled by the remote control and mayalso be operated by the energy supplied by the implantedenergy-transforming device 1002 to switch from an off mode, in which thebattery 1022 is not in use, to an on mode, in which the battery 1022supplies energy for the operation of the penile implant 10.

FIG. 50 shows an embodiment of the invention identical to that of FIG.49, except that an internal control unit 1015 controllable by thewireless remote control of the external energy-transmission device 1004also is implanted in the patient. In this case, the electric switch 1023is operated by the energy supplied by the implanted energy-transformingdevice 1002 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 1015 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 1015 torelease electric energy from the battery 1022 for the operation of thepenile implant 10. FIG. 51 shows an embodiment of the inventionidentical to that of FIG. 50, except that an accumulator 1016 issubstituted for the battery 1022 and the implanted components areinterconnected differently. In this case, the accumulator 1016 storesenergy from the implanted energy-transforming device 1002. In responseto a control signal from the wireless remote control of the externalenergy-transmission device 1004, the internal control unit 1015 controlsthe electric switch 1023 to switch from an off mode, in which theaccumulator 1016 is not in use, to an on mode, in which the accumulator1016 supplies energy for the operation of the penile implant 10. Theaccumulator may be combined with or replaced by a capacitor.

FIG. 52 shows an embodiment of the invention identical to that of FIG.51, except that a battery 1022 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 1004, the internal control unit 1015 controlsthe accumulator 1016 to deliver energy for operating the electric switch1023 to switch from an off mode, in which the battery 1022 is not inuse, to an on mode, in which the battery 1022 supplies electric energyfor the operation of the penile implant 10.

Alternatively, the electric switch 1023 may be operated by energysupplied by the accumulator 1016 to switch from an off mode, in whichthe wireless remote control is prevented from controlling the battery1022 to supply electric energy and is not in use, to a standby mode, inwhich the wireless remote control is permitted to control the battery1022 to supply electric energy for the operation of the penile implant10.

It should be understood that the switch 1023 and all other switches inthis application should be interpreted in its broadest embodiment. Thismeans a transistor, MCU, MCPU, ASIC, FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.Preferably the switch is controlled from outside the body, oralternatively by an implanted internal control unit.

FIG. 53 shows an embodiment of the invention identical to that of FIG.49, except that a motor 1007, a mechanical reversing device in the formof a gear box 1024, and an internal control unit 1015 for controllingthe gear box 1024 also are implanted in the patient. The internalcontrol unit 1015 controls the gear box 1024 to reverse the functionperformed by the penile implant 10 (mechanically operated). Even simpleris to switch the direction of the motor electronically. The gear boxinterpreted in its broadest embodiment may stand for a servo arrangementsaving force for the operation device in favour of longer stroke to act.

FIG. 54 shows an embodiment of the invention identical to that of FIG.60 except that the implanted components are interconnected differently.Thus, in this case the internal control unit 1015 is powered by thebattery 1022 when the accumulator 1016, suitably a capacitor, activatesthe electric switch 1023 to switch to an on mode. When the electricswitch 1023 is in its on mode the internal control unit 1015 ispermitted to control the battery 1022 to supply, or not supply, energyfor the operation of the penile implant 10.

FIG. 55 schematically shows conceivable combinations of implantedcomponents of the penile implant for achieving various communicationoptions. Basically, there are the penile implant 10, the internalcontrol unit 1015, motor or pump unit 1009, and the externalenergy-transmission device 1004 including the external wireless remotecontrol. As already described above the wireless remote controltransmits a control signal which is received by the internal controlunit 1015, which in turn controls the various implanted components ofthe penile implant.

A feedback device, preferably comprising a sensor or measuring device1025, may be implanted in the patient for sensing a physical parameterof the patient. The physical parameter may be at least one selected fromthe group consisting of pressure, volume, diameter, stretching,elongation, extension, movement, bending, elasticity, musclecontraction, nerve impulse, body temperature, blood pressure, bloodflow, heartbeats and breathing. The sensor may sense any of the abovephysical parameters. For example, the sensor may be a pressure ormotility sensor. Alternatively, the sensor 1025 may be arranged to sensea functional parameter. The functional parameter may be correlated tothe transfer of energy for charging an implanted energy source and mayfurther include at least one selected from the group of parametersconsisting of; electricity, any electrical parameter, pressure, volume,diameter, stretch, elongation, extension, movement, bending, elasticity,temperature and flow.

The feedback may be sent to the internal control unit or out to anexternal control unit preferably via the internal control unit. Feedbackmay be sent out from the body via the energy transfer system or aseparate communication system with receiver and transmitters.

The internal control unit 1015, or alternatively the external wirelessremote control of the external energy-transmission device 1004, maycontrol the penile implant 10 in response to signals from the sensor1025. A transceiver may be combined with the sensor 1025 for sendinginformation on the sensed physical parameter to the external wirelessremote control. The wireless remote control may comprise a signaltransmitter or transceiver and the internal control unit 1015 maycomprise a signal receiver or transceiver. Alternatively, the wirelessremote control may comprise a signal receiver or transceiver and theinternal control unit 1015 may comprise a signal transmitter ortransceiver. The above transceivers, transmitters and receivers may beused for sending information or data related to the penile implant 10from inside the patient's body to the outside thereof.

Where the motor/pump unit 1009 and battery 1022 for powering themotor/pump unit 1009 are implanted, information related to the chargingof the battery 1022 may be fed back. To be more precise, when charging abattery or accumulator with energy feed back information related to saidcharging process is sent and the energy supply is changed accordingly.

FIG. 56 shows an alternative embodiment wherein the penile implant 10 isregulated from outside the patient's body. The system 1000 comprises abattery 1022 connected to the penile implant 10 via a subcutaneouselectric switch 1026. Thus, the regulation of the penile implant 10 isperformed non-invasively by manually pressing the subcutaneous switch,whereby the operation of the penile implant 10 is switched on and off.It will be appreciated that the shown embodiment is a simplification andthat additional components, such as an internal control unit or anyother part disclosed in the present application can be added to thesystem. Two subcutaneous switches may also be used. In the preferredembodiment one implanted switch sends information to the internalcontrol unit to perform a certain predetermined performance and when thepatient press the switch again the performance is reversed.

FIG. 57 shows an alternative embodiment, wherein the system 1000comprises a hydraulic fluid reservoir 1013 hydraulically connected tothe penile implant. Non-invasive regulation is performed by manuallypressing the hydraulic reservoir connected to the penile implant.

The system may include an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator. The internal communicator feeds data related to the penileimplant or the patient to the external data communicator and/or theexternal data communicator feeds data to the internal data communicator.

FIG. 58 schematically illustrates an arrangement of the system that iscapable of sending information from inside the patient's body to theoutside thereof to give feedback information related to at least onefunctional parameter of the penile implant or system, or related to aphysical parameter of the patient, in order to supply an accurate amountof energy to an implanted internal energy receiver 1002 connected toimplanted energy consuming components of the penile implant 10. Such anenergy receiver 1002 may include an energy source and/or anenergy-transforming device. Briefly described, wireless energy istransmitted from an external energy source 1004 a located outside thepatient and is received by the internal energy receiver 1002 locatedinside the patient. The internal energy receiver is adapted to directlyor indirectly supply received energy to the energy consuming componentsof the penile implant 10 via a switch 1026. An energy balance isdetermined between the energy received by the internal energy receiver1002 and the energy used for the penile implant 10, and the transmissionof wireless energy is then controlled based on the determined energybalance. The energy balance thus provides an accurate indication of thecorrect amount of energy needed, which is sufficient to operate thepenile implant 10 properly, but without causing undue temperature rise.

In FIG. 58 the patient's skin is indicated by a vertical line 1005.Here, the energy receiver comprises an energy-transforming device 1002located inside the patient, preferably just beneath the patient's skin1005. Generally speaking, the implanted energy-transforming device 1002may be placed in the abdomen, thorax, muscle fascia (e.g. in theabdominal wall), subcutaneously, or at any other suitable location. Theimplanted energy-transforming device 1002 is adapted to receive wirelessenergy E transmitted from the external energy-source 1004 a provided inan external energy-transmission device 1004 located outside thepatient's skin 1005 in the vicinity of the implanted energy-transformingdevice 1002.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 1004 a and an adjacent secondary coil arranged inthe implanted energy-transforming device 1002. When an electric currentis fed through the primary coil, energy in the form of a voltage isinduced in the secondary coil which can be used to power the implantedenergy consuming components of the penile implant, e.g. after storingthe incoming energy in an implanted energy source, such as arechargeable battery or a capacitor. However, the present invention isgenerally not limited to any particular energy transfer technique, TETdevices or energy sources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of the penileimplant. The term “energy used” is then understood to include alsoenergy stored by implanted components of the penile implant. A controldevice includes an external control unit 1004 b that controls theexternal energy source 1004 a based on the determined energy balance toregulate the amount of transferred energy. In order to transfer thecorrect amount of energy, the energy balance and the required amount ofenergy is determined by means of a determination device including animplanted internal control unit 1015 connected between the switch 1026and the penile implant 10. The internal control unit 1015 may thus bearranged to receive various measurements obtained by suitable sensors orthe like, not shown, measuring certain characteristics of the penileimplant 10, somehow reflecting the required amount of energy needed forproper operation of the penile implant 10. Moreover, the currentcondition of the patient may also be detected by means of suitablemeasuring devices or sensors, in order to provide parameters reflectingthe patient's condition. Hence, such characteristics and/or parametersmay be related to the current state of the penile implant 10, such aspower consumption, operational mode and temperature, as well as thepatient's condition reflected by parameters such as; body temperature,blood pressure, heartbeats and breathing. Other kinds of physicalparameters of the patient and functional parameters of the device aredescribed elsewhere. Furthermore, an energy source in the form of anaccumulator 1016 may optionally be connected to the implantedenergy-transforming device 1002 via the control unit 1015 foraccumulating received energy for later use by the penile implant 10.Alternatively or additionally, characteristics of such an accumulator,also reflecting the required amount of energy, may be measured as well.The accumulator may be replaced by a rechargeable battery, and themeasured characteristics may be related to the current state of thebattery, any electrical parameter such as energy consumption voltage,temperature, etc. In order to provide sufficient voltage and current tothe penile implant 10, and also to avoid excessive heating, it isclearly understood that the battery should be charged optimally byreceiving a correct amount of energy from the implantedenergy-transforming device 1002, i.e. not too little or too much. Theaccumulator may also be a capacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 1015. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 1015 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the penile implant 10, or the patient, or an implanted energysource if used, or any combination thereof. The internal control unit1015 is further connected to an internal signal transmitter 1027,arranged to transmit a control signal reflecting the determined requiredamount of energy, to an external signal receiver 1004 c connected to theexternal control unit 1004 b. The amount of energy transmitted from theexternal energy source 1004 a may then be regulated in response to thereceived control signal.

Alternatively, the determination device may include the external controlunit 1004 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 1004 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 1004 b, thus integrating the above-describedfunction of the internal control unit 1015 in the external control unit1004 b. In that case, the internal control unit 1015 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 1027 which sends the measurements over to the externalsignal receiver 1004 c and the external control unit 1004 b. The energybalance and the currently required amount of energy can then bedetermined by the external control unit 1004 b based on those sensormeasurements.

Hence, the present solution according to the arrangement of FIG. 58employs the feed back of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming components of the penile implant. The penile implantmay use the received energy either for consuming or for storing theenergy in an implanted energy source or the like. The differentparameters discussed above would thus be used if relevant and needed andthen as a tool for determining the actual energy balance. However, suchparameters may also be needed per se for any actions taken internally tospecifically operate the penile implant.

The internal signal transmitter 1027 and the external signal receiver1004 c may be implemented as separate units using suitable signaltransfer means, such as radio, IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 1027 and the externalsignal receiver 1004 c may be integrated in the implantedenergy-transforming device 1002 and the external energy source 1004 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance with the presentinvention, such an integrated information feedback and energy systemcomprises an implantable internal energy receiver for receiving wirelessenergy, the energy receiver having an internal first coil and a firstelectronic circuit connected to the first coil, and an external energytransmitter for transmitting wireless energy, the energy transmitterhaving an external second coil and a second electronic circuit connectedto the second coil. The external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver. This system further comprises a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off. Inimplementing this system in the arrangement of FIG. 58, the switch 1026is either separate and controlled by the internal control unit 1015, orintegrated in the internal control unit 1015. It should be understoodthat the switch 1026 should be interpreted in its broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 58 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 1015 of the determinationdevice. A control signal reflecting the required amount of energy isalso created by the internal control unit 1015, and the control signalis transmitted from the internal signal transmitter 1027 to the externalsignal receiver 1004 c. Alternatively, the energy balance can bedetermined by the external control unit 1004 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external energy source 1004 a can then be regulated bythe external control unit 1004 b, based on the determined energybalance, e.g. in response to the received control signal. This processmay be repeated intermittently at certain intervals during ongoingenergy transfer, or may be executed on a more or less continuous basisduring the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 1004 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics.

This system may also be used to obtain information about the couplingfactors between the coils in a TET system even to calibrate the systemboth to find an optimal place for the external coil in relation to theinternal coil and to optimize energy transfer. Simply comparing in thiscase the amount of energy transferred with the amount of energyreceived. For example if the external coil is moved the coupling factormay vary and correctly displayed movements could cause the external coilto find the optimal place for energy transfer. Preferably, the externalcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.

This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorbetween the first and second coils. The energy transmitter may regulatethe transmitted energy in response to the obtained coupling factor.

With reference to FIG. 59, although wireless transfer of energy foroperating the penile implant has been described above to enablenon-invasive operation, it will be appreciated that the penile implantcan be operated with wire bound energy as well. Such an example is shownin FIG. 59, wherein an external switch 1026 is interconnected betweenthe external energy source 1004 a and an operation device, such as anelectric motor 1007 operating the penile implant 10. An external controlunit 1004 b controls the operation of the external switch 1026 to effectproper operation of the penile implant 10.

FIG. 60 illustrates different embodiments for how received energy can besupplied to and used by the penile implant 10. Similar to the example ofFIG. 58, an internal energy receiver 1002 receives wireless energy Efrom an external energy source 1004 a which is controlled by atransmission control unit 1004 b. The internal energy receiver 1002 maycomprise a constant voltage circuit, indicated as a dashed box “constantV” in the figure, for supplying energy at constant voltage to the penileimplant 10. The internal energy receiver 1002 may further comprise aconstant current circuit, indicated as a dashed box “constant C” in thefigure, for supplying energy at constant current to the penile implant10.

The penile implant 10 comprises an energy consuming part 10 a, which maybe a motor, pump, restriction device, or any other medical appliancethat requires energy for its electrical operation. The penile implant 10may further comprise an energy storage device 10 b for storing energysupplied from the internal energy receiver 1002. Thus, the suppliedenergy may be directly consumed by the energy consuming part 10 a, orstored by the energy storage device 10 b, or the supplied energy may bepartly consumed and partly stored. The penile implant 10 may furthercomprise an energy stabilizing unit 10 c for stabilizing the energysupplied from the internal energy receiver 1002. Thus, the energy may besupplied in a fluctuating manner such that it may be necessary tostabilize the energy before consumed or stored.

The energy supplied from the internal energy receiver 1002 may furtherbe accumulated and/or stabilized by a separate energy stabilizing unit1028 located outside the penile implant 10, before being consumed and/orstored by the penile implant 10. Alternatively, the energy stabilizingunit 1028 may be integrated in the internal energy receiver 1002. Ineither case, the energy stabilizing unit 1028 may comprise a constantvoltage circuit and/or a constant current circuit.

It should be noted that FIG. 58 and FIG. 60 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.

FIG. 61 schematically shows an energy balance measuring circuit of oneof the proposed designs of the system for controlling transmission ofwireless energy, or energy balance control system. The circuit has anoutput signal centered on 2.5V and proportionally related to the energyimbalance. The derivative of this signal shows if the value goes up anddown and how fast such a change takes place. If the amount of receivedenergy is lower than the energy used by implanted components of thepenile implant, more energy is transferred and thus charged into theenergy source. The output signal from the circuit is typically feed toan A/D converter and converted into a digital format. The digitalinformation can then be sent to the external energy-transmission deviceallowing it to adjust the level of the transmitted energy. Anotherpossibility is to have a completely analog system that uses comparatorscomparing the energy balance level with certain maximum and minimumthresholds sending information to external energy-transmission device ifthe balance drifts out of the max/min window.

The schematic FIG. 61 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the penileimplant of the present invention from outside of the patient's bodyusing inductive energy transfer. An inductive energy transfer systemtypically uses an external transmitting coil and an internal receivingcoil. The receiving coil, L1, is included in the schematic FIG. 44; thetransmitting parts of the system are excluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 61and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 61 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The components in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil L1.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

Those skilled in the art will realize that the above various embodimentsof the system could be combined in many different ways. For example, theelectric switch 1006 of FIG. 44 could be incorporated in any of theembodiments of FIGS. 47-53, the hydraulic valve shifting device 1014 ofFIG. 47 could be incorporated in the embodiment of FIG. 46, and the gearbox 1024 could be incorporated in the embodiment of FIG. 45. Pleaseobserve that the switch simply could mean any electronic circuit orcomponent.

The embodiments described in connection with FIGS. 58, 60 and 61identify a method and a system for controlling transmission of wirelessenergy to implanted energy consuming components of an electricallyoperable penile implant. Such a method and system will be defined ingeneral terms in the following.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of an penileimplant as described above. The wireless energy E is transmitted from anexternal energy source located outside the patient and is received by aninternal energy receiver located inside the patient, the internal energyreceiver being connected to the implanted energy consuming components ofthe penile implant for directly or indirectly supplying received energythereto. An energy balance is determined between the energy received bythe internal energy receiver and the energy used for the penile implant.The transmission of wireless energy E from the external energy source isthen controlled based on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external energy source to a secondary coil in the internal energyreceiver. A change in the energy balance may be detected to control thetransmission of wireless energy based on the detected energy balancechange. A difference may also be detected between energy received by theinternal energy receiver and energy used for the medical device, tocontrol the transmission of wireless energy based on the detected energydifference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the medical device may beconsumed to operate the medical device, and/or stored in at least oneenergy storage device of the medical device.

When electrical and/or physical parameters of the medical device and/orphysical parameters of the patient are determined, the energy may betransmitted for consumption and storage according to a transmission rateper time unit which is determined based on said parameters. The totalamount of transmitted energy may also be determined based on saidparameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external energy source maybe controlled by applying to the external energy source electricalpulses from a first electric circuit to transmit the wireless energy,the electrical pulses having leading and trailing edges, varying thelengths of first time intervals between successive leading and trailingedges of the electrical pulses and/or the lengths of second timeintervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied.

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external energysource may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

A system comprising an penile implant as described above is thus alsoprovided for controlling transmission of wireless energy supplied toimplanted energy consuming components of the penile implant. In itsbroadest sense, the system comprises a control device for controllingthe transmission of wireless energy from an energy-transmission device,and an implantable internal energy receiver for receiving thetransmitted wireless energy, the internal energy receiver beingconnected to implantable energy consuming components of the penileimplant for directly or indirectly supplying received energy thereto.The system further comprises a determination device adapted to determinean energy balance between the energy received by the internal energyreceiver and the energy used for the implantable energy consumingcomponents of the penile implant, wherein the control device controlsthe transmission of wireless energy from the externalenergy-transmission device, based on the energy balance determined bythe determination device.

Further, the system may comprise any of the following:

-   -   A primary coil in the external energy source adapted to transmit        the wireless energy inductively to a secondary coil in the        internal energy receiver.    -   The determination device is adapted to detect a change in the        energy balance, and the control device controls the transmission        of wireless energy based on the detected energy balance change    -   The determination device is adapted to detect a difference        between energy received by the internal energy receiver and        energy used for the implantable energy consuming components of        the penile implant, and the control device controls the        transmission of wireless energy based on the detected energy        difference.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy balance change implies that the energy        balance is increasing, or vice versa, wherein the        decrease/increase of energy transmission corresponds to a        detected change rate.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy difference implies that the received energy        is greater than the used energy, or vice versa, wherein the        decrease/increase of energy transmission corresponds to the        magnitude of said detected energy difference.    -   The energy used for the penile implant is consumed to operate        the penile implant, and/or stored in at least one energy storage        device of the penile implant.    -   Where electrical and/or physical parameters of the penile        implant and/or physical parameters of the patient are        determined, the energy-transmission device transmits the energy        for consumption and storage according to a transmission rate per        time unit which is determined by the determination device based        on said parameters. The determination device also determines the        total amount of transmitted energy based on said parameters.    -   When a difference is detected between the total amount of energy        received by the internal energy receiver and the total amount of        consumed and/or stored energy, and the detected difference is        related to the integral over time of at least one measured        electrical parameter related to the energy balance, the        determination device determines the integral for a monitored        voltage and/or current related to the energy balance.    -   When the derivative is determined over time of a measured        electrical parameter related to the amount of consumed and/or        stored energy, the determination device determines the        derivative for a monitored voltage and/or current related to the        energy balance.    -   The energy-transmission device comprises a coil placed        externally to the human body, and an electric circuit is        provided to power the external coil with electrical pulses to        transmit the wireless energy. The electrical pulses have leading        and trailing edges, and the electric circuit is adapted to vary        first time intervals between successive leading and trailing        edges and/or second time intervals between successive trailing        and leading edges of the electrical pulses to vary the power of        the transmitted wireless energy. As a result, the energy        receiver receiving the transmitted wireless energy has a varied        power.    -   The electric circuit is adapted to deliver the electrical pulses        to remain unchanged except varying the first and/or second time        intervals.    -   The electric circuit has a time constant and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the coil is varied.    -   The electric circuit is adapted to deliver the electrical pulses        to be varied by only varying the lengths of first time intervals        between successive leading and trailing edges of the electrical        pulses.    -   The electric circuit is adapted to supplying a train of two or        more electrical pulses in a row, said train having a first        electrical pulse at the start of the pulse train and having a        second electrical pulse at the end of the pulse train, and    -   the lengths of the second time intervals between successive        trailing edge of the second electrical pulse in a first pulse        train and leading edge of the first electrical pulse of a second        pulse train are varied by the first electronic circuit.    -   The electric circuit is adapted to provide the electrical pulses        as pulses having a substantially constant height and/or        amplitude and/or intensity and/or voltage and/or current and/or        frequency.    -   The electric circuit has a time constant, and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the first coil are varied.    -   The electric circuit is adapted to provide the electrical pulses        varying the lengths of the first and/or the second time        intervals only within a range that includes the first time        constant or that is located relatively close to the first time        constant, compared to the magnitude of the first time constant.

FIGS. 62-65 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering an implanted penile implantaccording to the invention.

FIG. 62 shows a system as described above with. The system comprises animplanted penile implant 10 and further a separate regulation reservoir1013, a one way pump 1009 and an alternate valve 1014.

FIG. 63 shows the penile implant 10 and a fluid reservoir 1013. Bymoving the wall of the regulation reservoir or changing the size of thesame in any other different way, the adjustment of the penile implantmay be performed without any valve, just free passage of fluid any timeby moving the reservoir wall.

FIG. 64 shows the penile implant 10, a two way pump 1009 and theregulation reservoir 1013.

FIG. 65 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 1013 and a servo reservoir 1050. Theservo reservoir 1050 mechanically controls an implanted penile implant10 via a mechanical interconnection 1054. The penile implant has anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 1052 in fluid connection with the penile implant 10.Alternatively, the cavity contains compressible gas, which can becompressed and expanded under the control of the servo reservoir 1050.

The servo reservoir 1050 can also be part of the penile implant itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patient's skin and is operated by pushing the outer surface thereofby means of a finger. This system is illustrated in FIGS. 25a-c . InFIG. 66a , a flexible subcutaneous regulation reservoir 1013 is shownconnected to a bulge shaped servo reservoir 1050 by means of a conduit1011. This bellow shaped servo reservoir 1050 is comprised in a aflexible penile implant 10. In the state shown in FIG. 66a , the servoreservoir 1050 contains a minimum of fluid and most fluid is found inthe regulation reservoir 1013. Due to the mechanical interconnectionbetween the servo reservoir 1050 and the penile implant 10, the outershape of the penile implant 10 is contracted, i.e., it occupies lessthan its maximum volume. This maximum volume is shown with dashed linesin the figure.

FIG. 66b shows a state wherein a user, such as the patient in with thepenile implant is implanted, presses the regulation reservoir 1013 sothat fluid contained therein is brought to flow through the conduit 1011and into the servo reservoir 1050, which, thanks to its bellow shape,expands longitudinally. This expansion in turn expands the penileimplant 10 so that it occupies its maximum volume, thereby stretchingthe stomach wall (not shown), which it contacts.

The regulation reservoir 1013 is preferably provided with means 1013 afor keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the penile implant 10in a stretched position also when the user releases the regulationreservoir. In this way, the regulation reservoir essentially operates asan on/off switch for the system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 67 and 68 a-c. The block diagramshown in FIG. 67 comprises with a first closed system controlling asecond closed system. The first system comprises a regulation reservoir1013 and a servo reservoir 1050. The servo reservoir 1050 mechanicallycontrols a larger adjustable reservoir 1052 via a mechanicalinterconnection 1054. An implanted penile implant 10 having anexpandable/contactable cavity is in turn controlled by the largeradjustable reservoir 1052 by supply of hydraulic fluid from the largeradjustable reservoir 1052 in fluid connection with the penile implant10.

An example of this embodiment will now be described with reference toFIG. 68a-c . Like in the previous embodiment, the regulation reservoiris placed subcutaneous under the patient's skin and is operated bypushing the outer surface thereof by means of a finger. The regulationreservoir 1013 is in fluid connection with a bellow shaped servoreservoir 1050 by means of a conduit 1011. In the first closed system1013, 1011, 1050 shown in FIG. 68a , the servo reservoir 1050 contains aminimum of fluid and most fluid is found in the regulation reservoir1013.

The servo reservoir 1050 is mechanically connected to a largeradjustable reservoir 1052, in this example also having a bellow shapebut with a larger diameter than the servo reservoir 1050. The largeradjustable reservoir 1052 is in fluid connection with the penile implant10. This means that when a user pushes the regulation reservoir 1013,thereby displacing fluid from the regulation reservoir 1013 to the servoreservoir 1050, the expansion of the servo reservoir 1050 will displacea larger volume of fluid from the larger adjustable reservoir 1052 tothe penile implant 10. In other words, in this reversed servo, a smallvolume in the regulation reservoir is compressed with a higher force andthis creates a movement of a larger total area with less force per areaunit.

Like in the previous embodiment described above with reference to FIGS.66a-c , the regulation reservoir 1013 is preferably provided with means1013 a for keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the penile implant 10in a stretched position also when the user releases the regulationreservoir. In this way, the regulation reservoir essentially operates asan on/off switch for the system.

Of course a penile implant 10 according to any embodiment and comprisingany aspect or feature can be part of a penile prosthesis system 700 andbe connected to a manual or powered operating device 702 and a controldevice 704 and be part of a penile prosthesis system.

In one embodiment, the method of implanting the penile implant comprisesthe steps of:

cutting the skin,

dissecting the area of corpus cavernosum,

implanting the implant in corpus cavernosum, and

closing the wound.

In one embodiment, the method implanting the system comprises the stepsof:

cutting the skin,

implanting the energizing and control systems subcutaneously in theabdomen or pelvic region of the body, and

closing the wound.

Although particular embodiments have been disclosed herein in detail,this has been done by way of example for purposes of illustration only,and is not intended to be limiting with respect to the scope of theappended claims that follow. In particular, it is contemplated by theinventor that various substitutions, alterations, and modifications maybe made to the invention without departing from the spirit and scope ofthe invention as defined by the claims.

The invention claimed is:
 1. An method of implanting a penile implantfor curing impotence of a patient, comprising: cutting a skin of thepatient, dissecting an area of a corpus cavernosum of a penis of thepatient, implanting the penile implant in the corpus cavernosum by:placing a relatively short proximal portion of the penile implant in theroot of the penis, and placing a flexible relatively long distal portionof the penile implant such that it extends along or in the pendulous orprotruding part of the penis, such that a bending portion of said penileimplant is placed or located between the proximal and distal portion, orin the vicinity of the position where the proximal and distal portionmeet, wherein the penile implant is adapted to be postoperatively andnon-invasively adjustable to selectively assume an inactivated state, inwhich said penis is flaccid, and an activated state, in which said penisis erected, wherein said bending portion is adapted to enable saidpenile implant, when said penile implant is implanted and activated, tobring at least the pendulous or protruding portion of the penis to aposition in which the penis has an acute angle with the vertical planewhen said person is standing, that is, a position in which at least thependulous or protruding portion of the penis is upwardly bent when saidperson is standing, and in which position the distal portion is moreupwardly oriented than the proximal portion, wherein said bendingportion comprises at least one of: a bellows structure, which extendsalong a part of, along parts of, or along the complete, circumference ofsaid penile implant, wherein said bellows structure is designed so thatat least part of the underside of said penile implant shows a greaterlength expansion when said penile implant is brought into said activatedstate, and a pliable top wall and a pliable bottom wall, said bottomwall being designed to longitudinally distend more than said top wall,when said penile implant is brought into said activated state.
 2. Themethod of implanting a penile implant for curing impotence according toclaim 1, further comprising, after the step of cutting the skin of thepatient, the additional step of: inserting a tube or needle into thepatient's body, filling the tube or needle with a gas and therebyexpanding a cavity within the male patient's body, inserting at leasttwo laparoscopic trocars into said cavity, inserting at least one camerathrough at least one laparoscopic trocar, inserting at least onedissecting tool through at least one laparoscopic trocar, wherein thestep of dissecting the area of the corpus cavernosum comprises using theat least one dissecting tool dissecting the area.
 3. The method ofimplanting a penile implant for curing impotence according to claim 1,further comprising the step of implanting an energizing and controlsystem in at least one of the following positions of the body:subcutaneously, in the abdomen, and in the pelvic region.
 4. The methodof implanting a penile implant for curing impotence according to claim1, further comprising the step of placing an operation device and apower source within the body.
 5. The method of implanting a penileimplant for curing impotence according to claim 4, further comprisingthe step of placing the penile implant comprising an operation device asan integrated unit.
 6. The method of implanting a penile implant forcuring impotence according to claim 1, further comprising, placingremote from said sexually responsive tissue at least one of thefollowing: placing a power source, placing a control unit, and arechargeable battery.
 7. The method of implanting a penile implant forcuring impotence according to claim 1, further comprising the step of:implanting a push bottom under the skin, and providing a remote control,allowing at least one of the following steps: controlling said penileimplant during implantation and controlling said penile implantpost-operatively and non-invasively from outside the body, to adjust bythe remote control or the push bottom under the skin the penile implantto its erected state.
 8. The method of implanting a penile implant forcuring impotence according to claim 1, wherein at least one of: saidbellows structure has a greater longitudinal extension on the undersidethan on the upper side of said penile implant, and said bellowsstructure has a greater depth, at least when said penile implant is init's in- or non-activated state, on the underside than on the upper sideof said penile implant.
 9. The method of implanting a penile implant forcuring impotence according to claim 1, wherein said bottom wall of saidproximal portion forms circumferentially extending alternating ridgesand grooves, whereby said bottom wall behaves like an expanding bellowswhen said penile implant is brought into said activated state, whereinsaid ridges of said bottom wall are spaced apart from one another, whensaid penile implant is in its inactivated state, wherein said top wallforms circumferentially extending alternating ridges and groovesdimensioned such that said top wall longitudinally distends less thansaid bottom wall, when said penile implant is brought into said secondactivated state.
 10. The method of implanting a penile implant forcuring impotence according to claim 1, further comprising the step ofpost-operatively and non-invasively expanding an expandable section, forthe penile implant to reach its erected state.
 11. The method ofimplanting a penile implant for curing impotence according to claim 1,the penile implant comprising, at least one sealed hollow space in theimplant adapted to receive a fluid, a reservoir adapted to hold saidfluid, a powered pump, wherein the operation method comprising theadditional step of: —moving fluid from said reservoir to said hollowsealed space, creating pressure in a chamber in said reservoir causingsaid erected state.
 12. The method of implanting a penile implant forcuring impotence according to claim 10, wherein said elongated implantis structured to have at least one end of the elongated implantinvaginated in itself in its longitudinal direction, thus making theelongated implant shorter when the at least one end is invaginated, andwherein said invagination is adapted to provide the expansion, being theexpandable section, when the invagination is withdrawn.
 13. The methodof implanting a penile implant for curing impotence according to claim10, wherein said proximal portion of said penile implant is made of anelastic material.
 14. The method of implanting a penile implant forcuring impotence according to claim 1, wherein said penile implantcomprises at least one expandable portion comprising at least one chosenfrom the group of; a radially expandable portion, a radially expandablesegment, a longitudinally expandable portion, and a longitudinallyexpandable segment, wherein said penile implant has a predeterminedshape with a length and a diameter, wherein the method comprisingimplanting the penile implant adapted to allow an increase of the penileimplant in at least one of the following; increased penile diameter,increased penile length, and increased penile length and diameter whensaid penile implant is implanted and in the activated state, as comparedto the flaccid status of the penis.
 15. The method of implanting apenile implant for curing impotence according to claim 1, wherein saidpenile implant at least partly comprises a hollow space at least partlyfilled with a hollow body, comprising closed spaces, suitably bubbles,which contain, or are filled with, a solid material, a foam material, agas or a fluid, said closed spaces being arranged to delimiting thehollow part of said penile implant.
 16. The method of implanting apenile implant for curing impotence according to claim 1, wherein saidbending portion comprising a pre-formed section shaped to give thepenile implant a shape that corresponds to or resembles the shape thatthe penile implant has most of the time, when implanted, thus, thepre-formed section is shaped in a way as to give the penile implant ashape that corresponds to or resembles the shape of a relaxed penis, tominimize the stress on the material of the implant.
 17. The method ofimplanting a penile implant for curing impotence according to claim 1,wherein the pre-formed section, comprises a surface shape having atleast one of; a fold, a pleat, a thicker wall part, a thinner wall part,an indentation, concaveness, a pliable wall, and bellow shaped part. 18.The method of implanting a penile implant for curing impotence accordingto claim 1, further comprising the step of comprising a longitudinallyexpandable portion or a longitudinally expandable segment on a proximalpart of said penile implant.
 19. The method of implanting a penileimplant for curing impotence according to claim 1, further comprisingthe step of: implanting a second penile implant, placing the two penileimplants in the two corpus cavernosum, one in each corpus cavernosum.20. The method of implanting a penile implant for curing impotenceaccording to claim 1, wherein the penile implants each comprising atleast one radially expandable portion or a radially expandable segment,along its longitudinal extension comprising in each penile implant oneconcaveness or one indentation, adapted to substantially face theurethra, and wherein the concaveness or the indentation of both thefirst and second penile implant is constructed to face both face theurethra or each other, when the penile implants are implanted inrespective corpus cavernosum, and thereby allowing the additional stepof radially expanding the penile implant.